{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T04:31:01Z","timestamp":1789446661099,"version":"build-2803163510"},"reference-count":59,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T00:00:00Z","timestamp":1731110400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T00:00:00Z","timestamp":1731110400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract\n<\/jats:title><jats:sec>\n                <jats:title>Background\n<\/jats:title>\n                <jats:p>Polycystic ovary syndrome (PCOS), the most common endocrine disorder for women of reproductive age, is associated with increased risk for insulin resistance and type 2 diabetes. Current PCOS treatments insufficiently address the spectrum and severity of the disorder, and there is little evidence-based guidance available for lifestyle management of PCOS, especially through nutritional approaches. Some evidence shows that a very low-carbohydrate diet can improve glucose control compared to low-fat or moderate-carbohydrate diets, leading to improved glucose control and insulin levels that may help to treat symptoms of PCOS. This research investigates whether a very low-carbohydrate diet is more effective in improving glucose control and decreasing symptoms of PCOS in comparison to a DASH diet.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The SUPER study aims to address the gap in knowledge about nutritional advice for people with PCOS through a randomized, comparative effectiveness trial comparing two approaches to glucose control: the dietary approaches to stopping hypertension (DASH) diet, and a very low-carbohydrate (VLC) diet. We will randomize 184 women with PCOS with body mass indexes (BMIs) between 25 and 50\u00a0kg\/m<jats:sup>2<\/jats:sup> to a VLC or DASH diet. All participants will follow a 24-session, 12-month, online diet, and lifestyle intervention that teaches their assigned diet. Participants will receive nutritional education, support from diet coaches, and education about behavioral strategies to improve dietary adherence. The primary outcome measure is HbA1c, and secondary outcomes include glucose variance, lipid and hormone levels (including total and free testosterone), PCOS symptoms, inflammation (measured by high-sensitivity C-reactive protein), body composition and weight, psychological well-being, and intervention feasibility and acceptability.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The SUPER study is a randomized comparative effectiveness trial that compares two promising approaches to glucose control in people with PCOS. The study also aims to assess the effects of each diet on PCOS symptoms. The research addresses an important gap in knowledge regarding nutritional advice for people with PCOS.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT05452642. Registered 6 July 2022.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08583-y","type":"journal-article","created":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T01:51:18Z","timestamp":1731117078000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Protocol for a randomized comparative effectiveness trial comparing a very low-carbohydrate diet to DASH diet for polycystic ovary syndrome: the SUPER (Supporting Understanding of PCOS Education and Research) trial"],"prefix":"10.1186","volume":"25","author":[{"given":"Sarah","family":"Greenwell","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aubree","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yolanda R.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deanna","family":"Marriott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James E.","family":"Aikens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vasantha","family":"Padmanabhan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3991-3205","authenticated-orcid":false,"given":"Laura R.","family":"Saslow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,9]]},"reference":[{"issue":"1","key":"8583_CR1","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1016\/j.mcna.2014.09.003","volume":"99","author":"S Trikudanathan","year":"2015","unstructured":"Trikudanathan S. Polycystic ovarian syndrome. Med Clin North Am. 2015;99(1):221\u201335. https:\/\/doi.org\/10.1016\/j.mcna.2014.09.003.","journal-title":"Med Clin North Am"},{"issue":"4","key":"8583_CR2","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1093\/humupd\/dmr001","volume":"17","author":"P De Groot","year":"2011","unstructured":"De Groot P, Dekkers O, Romijn J, Dieben S, Helmerhorst F. PCOS, coronary heart disease, stroke and the influence of obesity: a systematic review and meta-analysis. Hum Reprod Update. 2011;17(4):495\u2013500. https:\/\/doi.org\/10.1093\/humupd\/dmr001.","journal-title":"Hum Reprod Update"},{"issue":"1","key":"8583_CR3","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1093\/humrep\/deh098","volume":"19","author":"E Rotterdam","year":"2004","unstructured":"Rotterdam E, ASRM-Sponsored P. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004;19(1):41. https:\/\/doi.org\/10.1093\/humrep\/deh098.","journal-title":"Hum Reprod"},{"issue":"10","key":"8583_CR4","first-page":"591","volume":"13","author":"A Jalilian","year":"2015","unstructured":"Jalilian A, Kiani F, Sayehmiri F, Sayehmiri K, Khodaee Z, Akbari M. Prevalence of polycystic ovary syndrome and its associated complications in Iranian women: a meta-analysis. Iran J Reprod Med. 2015;13(10):591\u2013604.","journal-title":"Iran J Reprod Med"},{"issue":"6","key":"8583_CR5","doi-asserted-by":"publisher","first-page":"638","DOI":"10.1093\/humupd\/dms029","volume":"18","author":"SM Veltman-Verhulst","year":"2012","unstructured":"Veltman-Verhulst SM, Boivin J, Eijkemans MJ, Fauser BJ. Emotional distress is a common risk in women with polycystic ovary syndrome: a systematic review and meta-analysis of 28 studies. Hum Reprod Update. 2012;18(6):638\u201351. https:\/\/doi.org\/10.1093\/humupd\/dms029.","journal-title":"Hum Reprod Update"},{"issue":"8","key":"8583_CR6","doi-asserted-by":"publisher","first-page":"4650","DOI":"10.1210\/jc.2005-0628","volume":"90","author":"R Azziz","year":"2005","unstructured":"Azziz R, Marin C, Hoq L, Badamgarav E, Song P. Health care-related economic burden of the polycystic ovary syndrome during the reproductive life span. J Clin Endocrinol Metab. 2005;90(8):4650\u20138. https:\/\/doi.org\/10.1210\/jc.2005-0628.","journal-title":"J Clin Endocrinol Metab"},{"issue":"2","key":"8583_CR7","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1089\/obe.2007.0019","volume":"3","author":"S Sam","year":"2007","unstructured":"Sam S. Obesity and polycystic ovary syndrome. Obes Manag. 2007;3(2):69\u201373. https:\/\/doi.org\/10.1089\/obe.2007.0019.","journal-title":"Obes Manag"},{"issue":"2","key":"8583_CR8","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1111\/j.1467-789X.2012.01053.x","volume":"14","author":"SS Lim","year":"2013","unstructured":"Lim SS, Norman RJ, Davies MJ, Moran LJ. The effect of obesity on polycystic ovary syndrome: a systematic review and meta-analysis. Obes Rev. 2013;14(2):95\u2013109. https:\/\/doi.org\/10.1111\/j.1467-789X.2012.01053.x.","journal-title":"Obes Rev"},{"issue":"4","key":"8583_CR9","doi-asserted-by":"publisher","first-page":"455","DOI":"10.1093\/humupd\/dmy007","volume":"24","author":"NS Kakoly","year":"2018","unstructured":"Kakoly NS, Khomami MB, Joham AE, et al. Ethnicity, obesity and the prevalence of impaired glucose tolerance and type 2 diabetes in PCOS: a systematic review and meta-regression. Hum Reprod Update. 2018;24(4):455\u201367. https:\/\/doi.org\/10.1093\/humupd\/dmy007.","journal-title":"Hum Reprod Update"},{"issue":"6","key":"8583_CR10","doi-asserted-by":"publisher","first-page":"E1088","DOI":"10.1210\/jc.2013-1295","volume":"98","author":"U Ezeh","year":"2013","unstructured":"Ezeh U, Yildiz BO, Azziz R. Referral bias in defining the phenotype and prevalence of obesity in polycystic ovary syndrome. J Clin Endocrinol Metab. 2013;98(6):E1088\u201396. https:\/\/doi.org\/10.1210\/jc.2013-1295.","journal-title":"J Clin Endocrinol Metab"},{"issue":"1","key":"8583_CR11","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1210\/jc.2007-1834","volume":"93","author":"BO Yildiz","year":"2008","unstructured":"Yildiz BO, Knochenhauer ES, Azziz R. Impact of obesity on the risk for polycystic ovary syndrome. J Clin Endocrinol Metab. 2008;93(1):162\u20138. https:\/\/doi.org\/10.1210\/jc.2007-1834.","journal-title":"J Clin Endocrinol Metab"},{"issue":"2","key":"8583_CR12","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1007\/s13679-017-0262-y","volume":"6","author":"DH Ryan","year":"2017","unstructured":"Ryan DH, Yockey SR. Weight loss and improvement in comorbidity: differences at 5%, 10%, 15%, and over. Curr Obes Rep. 2017;6(2):187\u201394. https:\/\/doi.org\/10.1007\/s13679-017-0262-y.","journal-title":"Curr Obes Rep"},{"issue":"6","key":"8583_CR13","doi-asserted-by":"publisher","first-page":"1966","DOI":"10.1016\/j.fertnstert.2008.09.018","volume":"92","author":"LJ Moran","year":"2009","unstructured":"Moran LJ, Pasquali R, Teede HJ, Hoeger KM, Norman RJ. Treatment of obesity in polycystic ovary syndrome: a position statement of the Androgen Excess and Polycystic Ovary Syndrome Society. Fertil Steril. 2009;92(6):1966\u201382. https:\/\/doi.org\/10.1016\/j.fertnstert.2008.09.018.","journal-title":"Fertil Steril"},{"issue":"5","key":"8583_CR14","doi-asserted-by":"publisher","first-page":"2038","DOI":"10.1210\/jc.2009-2724","volume":"95","author":"RA Wild","year":"2010","unstructured":"Wild RA, Carmina E, Diamanti-Kandarakis E, et al. Assessment of cardiovascular risk and prevention of cardiovascular disease in women with the polycystic ovary syndrome: a consensus statement by the Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society. J Clin Endocrinol Metab. 2010;95(5):2038\u201349. https:\/\/doi.org\/10.1210\/jc.2009-2724.","journal-title":"J Clin Endocrinol Metab"},{"issue":"12","key":"8583_CR15","doi-asserted-by":"publisher","first-page":"4565","DOI":"10.1210\/jc.2013-2350","volume":"98","author":"RS Legro","year":"2013","unstructured":"Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(12):4565\u201392. https:\/\/doi.org\/10.1210\/jc.2013-2350.","journal-title":"J Clin Endocrinol Metab"},{"issue":"9","key":"8583_CR16","doi-asserted-by":"publisher","first-page":"1928","DOI":"10.1093\/humrep\/deg367","volume":"18","author":"PG Crosignani","year":"2003","unstructured":"Crosignani PG, Colombo M, Vegetti W, Somigliana E, Gessati A, Ragni G. Overweight and obese anovulatory patients with polycystic ovaries: parallel improvements in anthropometric indices, ovarian physiology and fertility rate induced by diet. Hum Reprod. 2003;18(9):1928\u201332. https:\/\/doi.org\/10.1093\/humrep\/deg367.","journal-title":"Hum Reprod"},{"key":"8583_CR17","doi-asserted-by":"publisher","first-page":"S429","DOI":"10.1016\/j.dsx.2017.03.030","volume":"11","author":"Z Faghfoori","year":"2017","unstructured":"Faghfoori Z, Fazelian S, Shadnoush M, Goodarzi R. Nutritional management in women with polycystic ovary syndrome: a review study. Diabetes Metab Syndr. 2017;11:S429\u201332. https:\/\/doi.org\/10.1016\/j.dsx.2017.03.030.","journal-title":"Diabetes Metab Syndr"},{"issue":"4","key":"8583_CR18","doi-asserted-by":"publisher","first-page":"520","DOI":"10.1016\/j.jand.2012.11.018","volume":"113","author":"LJ Moran","year":"2013","unstructured":"Moran LJ, Ko H, Misso M, et al. Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. J Acad Nutr Diet. 2013;113(4):520\u201345. https:\/\/doi.org\/10.1016\/j.jand.2012.11.018.","journal-title":"J Acad Nutr Diet"},{"issue":"9","key":"8583_CR19","doi-asserted-by":"publisher","first-page":"1602","DOI":"10.1093\/humrep\/dey256","volume":"33","author":"HJ Teede","year":"2018","unstructured":"Teede HJ, Misso ML, Costello MF, et al. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018;33(9):1602\u201318. https:\/\/doi.org\/10.1093\/humrep\/dey256.","journal-title":"Hum Reprod"},{"issue":"1","key":"8583_CR20","first-page":"57","volume":"41","author":"JM Frary","year":"2016","unstructured":"Frary JM, Bjerre KP, Glintborg D, Ravn P. The effect of dietary carbohydrates in women with polycystic ovary syndrome: a systematic review. Minerva Endocrinol. 2016;41(1):57\u201369.","journal-title":"Minerva Endocrinol"},{"issue":"3","key":"8583_CR21","doi-asserted-by":"publisher","first-page":"300","DOI":"10.1177\/0884533611405791","volume":"26","author":"AH Hite","year":"2011","unstructured":"Hite AH, Berkowitz VG, Berkowitz K. Low-carbohydrate diet review: shifting the paradigm. Nutr Clin Pract. 2011;26(3):300\u20138. https:\/\/doi.org\/10.1177\/0884533611405791.","journal-title":"Nutr Clin Pract"},{"issue":"2","key":"8583_CR22","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1097\/00006254-199702000-00017","volume":"52","author":"JE Nestler","year":"1997","unstructured":"Nestler JE, Jakubowicz DJ. Decreases in ovarian cytochrome P450c17 alpha activity and serum free testosterone after reduction of insulin secretion in polycystic ovary syndrome. Obstet Gynecol Surv. 1997;52(2):112\u20134. https:\/\/doi.org\/10.1097\/00006254-199702000-00017.","journal-title":"Obstet Gynecol Surv"},{"issue":"1","key":"8583_CR23","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1210\/jcem.84.1.5393","volume":"84","author":"RS Legro","year":"1999","unstructured":"Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999;84(1):165\u20139. https:\/\/doi.org\/10.1210\/jcem.84.1.5393.","journal-title":"J Clin Endocrinol Metab"},{"issue":"6","key":"8583_CR24","doi-asserted-by":"publisher","first-page":"774","DOI":"10.1210\/edrv.18.6.0318","volume":"18","author":"A Dunaif","year":"1997","unstructured":"Dunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997;18(6):774\u2013800. https:\/\/doi.org\/10.1210\/edrv.18.6.0318.","journal-title":"Endocr Rev"},{"issue":"4","key":"8583_CR25","doi-asserted-by":"publisher","first-page":"550","DOI":"10.1111\/cen.12175","volume":"79","author":"BA Gower","year":"2013","unstructured":"Gower BA, Chandler-Laney PC, Ovalle F, et al. Favourable metabolic effects of a eucaloric lower-carbohydrate diet in women with PCOS. Clin Endocrinol (Oxf). 2013;79(4):550\u20137. https:\/\/doi.org\/10.1111\/cen.12175.","journal-title":"Clin Endocrinol (Oxf)"},{"key":"8583_CR26","doi-asserted-by":"publisher","DOI":"10.1186\/1743-7075-2-35","volume":"2","author":"JC Mavropoulos","year":"2005","unstructured":"Mavropoulos JC, Yancy WS, Hepburn J, Westman EC. The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Nutr Metab (Lond). 2005;2: 35. https:\/\/doi.org\/10.1186\/1743-7075-2-35.","journal-title":"Nutr Metab (Lond)"},{"issue":"1","key":"8583_CR27","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1016\/j.jada.2007.10.003","volume":"108","author":"JK Kirk","year":"2008","unstructured":"Kirk JK, Graves DE, Craven TE, Lipkin EW, Austin M, Margolis KL. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis. J Am Diet Assoc. 2008;108(1):91\u2013100. https:\/\/doi.org\/10.1016\/j.jada.2007.10.003.","journal-title":"J Am Diet Assoc"},{"issue":"2","key":"8583_CR28","doi-asserted-by":"publisher","DOI":"10.4172\/2165-7904.1000259","volume":"5","author":"JL Phy","year":"2015","unstructured":"Phy JL, Pohlmeier AM, Cooper JA, et al. Low starch\/low dairy diet results in successful treatment of obesity and co-morbidities linked to polycystic ovary syndrome (PCOS). J Obes Weight Loss Ther. 2015;5(2): 259. https:\/\/doi.org\/10.4172\/2165-7904.1000259.","journal-title":"J Obes Weight Loss Ther"},{"issue":"1","key":"8583_CR29","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1186\/s12967-020-02277-0","volume":"18","author":"A Paoli","year":"2020","unstructured":"Paoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020;18(1):104. https:\/\/doi.org\/10.1186\/s12967-020-02277-0.","journal-title":"J Transl Med"},{"issue":"3","key":"8583_CR30","doi-asserted-by":"publisher","first-page":"1145","DOI":"10.1111\/jog.14650","volume":"47","author":"J Li","year":"2021","unstructured":"Li J, Bai WP, Jiang B, et al. Ketogenic diet in women with polycystic ovary syndrome and liver dysfunction who are obese: a randomized, open-label, parallel-group, controlled pilot trial. J Obstet Gynaecol Res. 2021;47(3):1145\u201352. https:\/\/doi.org\/10.1111\/jog.14650.","journal-title":"J Obstet Gynaecol Res"},{"issue":"18","key":"8583_CR31","doi-asserted-by":"publisher","first-page":"3872","DOI":"10.3390\/nu15183872","volume":"15","author":"H Deshmukh","year":"2023","unstructured":"Deshmukh H, Papageorgiou M, Wells L, et al. The effect of a very-low-calorie diet (VLCD) vs. a moderate energy deficit diet in obese women with polycystic ovary syndrome (PCOS)-a randomised controlled trial. Nutrients. 2023;15(18):3872. https:\/\/doi.org\/10.3390\/nu15183872.","journal-title":"Nutrients"},{"issue":"4","key":"8583_CR32","doi-asserted-by":"publisher","first-page":"386","DOI":"10.1016\/J.XFRE.2021.08.008","volume":"2","author":"AL Missel","year":"2021","unstructured":"Missel AL, O\u2019Brien AV, Maser H, et al. Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study. F S Rep. 2021;2(4):386\u201395. https:\/\/doi.org\/10.1016\/J.XFRE.2021.08.008.","journal-title":"F S Rep"},{"issue":"3","key":"8583_CR33","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1055\/s-0034-1376990","volume":"47","author":"Z Asemi","year":"2015","unstructured":"Asemi Z, Esmaillzadeh A. DASH diet, insulin resistance, and serum hs-CRP in polycystic ovary syndrome: a randomized controlled clinical trial. Horm Metab Res. 2015;47(3):232\u20138. https:\/\/doi.org\/10.1055\/s-0034-1376990.","journal-title":"Horm Metab Res"},{"issue":"1","key":"8583_CR34","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1111\/cen.13333","volume":"87","author":"F Foroozanfard","year":"2017","unstructured":"Foroozanfard F, Rafiei H, Samimi M, et al. The effects of dietary approaches to stop hypertension diet on weight loss, anti-M\u00fcllerian hormone and metabolic profiles in women with polycystic ovary syndrome: a randomized clinical trial. Clin Endocrinol (Oxf). 2017;87(1):51\u20138. https:\/\/doi.org\/10.1111\/cen.13333.","journal-title":"Clin Endocrinol (Oxf)"},{"issue":"1","key":"8583_CR35","doi-asserted-by":"publisher","first-page":"882","DOI":"10.1186\/s12889-023-15730-8","volume":"23","author":"MS Butt","year":"2023","unstructured":"Butt MS, Saleem J, Zakar R, Aiman S, Khan MZ, Fischer F. Benefits of physical activity on reproductive health functions among polycystic ovarian syndrome women: a systematic review. BMC Public Health. 2023;23(1):882. https:\/\/doi.org\/10.1186\/s12889-023-15730-8.","journal-title":"BMC Public Health"},{"issue":"12","key":"8583_CR36","doi-asserted-by":"publisher","first-page":"2165","DOI":"10.2337\/diacare.25.12.2165","volume":"25","author":"The Diabetes Prevention Program (DPP) Research Group","year":"2002","unstructured":"The Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25(12):2165\u201371. https:\/\/doi.org\/10.2337\/diacare.25.12.2165.","journal-title":"Diabetes Care"},{"key":"8583_CR37","doi-asserted-by":"publisher","unstructured":"Saslow LR, Missel AL, O\u2019Brien A, Kim S, Hecht FM, Moskowitz JT, Bayandorian H, Pietrucha M, Raymond K, Richards B, Liestenfeltz B, Mason AE, Daubenmier J, Aikens JE. Psychological support strategies for adults with type 2 diabetes in a very low\u2013carbohydrate web-based program: randomized controlled trial. JMIR Diabetes. 2023;8:e44295. https:\/\/doi.org\/10.2196\/44295.","DOI":"10.2196\/44295"},{"issue":"7258","key":"8583_CR38","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1136\/bmj.321.7258.405","volume":"321","author":"IM Stratton","year":"2000","unstructured":"Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405\u201312. https:\/\/doi.org\/10.1136\/bmj.321.7258.405.","journal-title":"BMJ"},{"issue":"10","key":"8583_CR39","doi-asserted-by":"publisher","first-page":"18381","DOI":"10.3390\/ijms151018381","volume":"15","author":"Y Saisho","year":"2014","unstructured":"Saisho Y. Glycemic variability and oxidative stress: a link between diabetes and cardiovascular disease? Int J Mol Sci. 2014;15(10):18381\u2013406. https:\/\/doi.org\/10.3390\/ijms151018381.","journal-title":"Int J Mol Sci"},{"issue":"6","key":"8583_CR40","doi-asserted-by":"publisher","first-page":"810","DOI":"10.1111\/j.1365-2265.2011.04205.x","volume":"76","author":"C Wang","year":"2012","unstructured":"Wang C, Lv L, Yang Y, et al. Glucose fluctuations in subjects with normal glucose tolerance, impaired glucose regulation and newly diagnosed type 2 diabetes mellitus. Clin Endocrinol (Oxf). 2012;76(6):810\u20135. https:\/\/doi.org\/10.1111\/j.1365-2265.2011.04205.x.","journal-title":"Clin Endocrinol (Oxf)"},{"issue":"6","key":"8583_CR41","doi-asserted-by":"publisher","first-page":"1487","DOI":"10.2337\/diacare.27.6.1487","volume":"27","author":"TM Wallace","year":"2004","unstructured":"Wallace TM, Levy JC, Matthews DR. Use and abuse of HOMA modeling. Diabetes Care. 2004;27(6):1487\u201395. https:\/\/doi.org\/10.2337\/diacare.27.6.1487.","journal-title":"Diabetes Care"},{"issue":"1","key":"8583_CR42","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1161\/01.cir.100.1.96","volume":"100","author":"WK Lagrand","year":"1999","unstructured":"Lagrand WK, Visser CA, Hermens WT, et al. C-reactive protein as a cardiovascular risk factor: more than an epiphenomenon? Circulation. 1999;100(1):96\u2013102. https:\/\/doi.org\/10.1161\/01.cir.100.1.96.","journal-title":"Circulation"},{"issue":"1","key":"8583_CR43","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1016\/j.trsl.2015.06.017","volume":"167","author":"FK Welty","year":"2016","unstructured":"Welty FK, Alfaddagh A, Elajami TK. Targeting inflammation in metabolic syndrome. Transl Res. 2016;167(1):257\u201380. https:\/\/doi.org\/10.1016\/j.trsl.2015.06.017.","journal-title":"Transl Res"},{"issue":"3","key":"8583_CR44","doi-asserted-by":"publisher","first-page":"263","DOI":"10.1038\/nm.3804","volume":"21","author":"YH Youm","year":"2015","unstructured":"Youm YH, Nguyen KY, Grant RW, et al. The ketone metabolite beta-hydroxybutyrate blocks NLRP3 inflammasome-mediated inflammatory disease. Nat Med. 2015;21(3):263\u20139. https:\/\/doi.org\/10.1038\/nm.3804.","journal-title":"Nat Med"},{"issue":"9","key":"8583_CR45","doi-asserted-by":"publisher","first-page":"2077","DOI":"10.1016\/j.celrep.2017.02.004","volume":"18","author":"EL Goldberg","year":"2017","unstructured":"Goldberg EL, Asher JL, Molony RD, et al. Beta-hydroxybutyrate deactivates neutrophil NLRP3 inflammasome to relieve gout flares. Cell Rep. 2017;18(9):2077\u201387. https:\/\/doi.org\/10.1016\/j.celrep.2017.02.004.","journal-title":"Cell Rep"},{"issue":"8","key":"8583_CR46","doi-asserted-by":"publisher","first-page":"993","DOI":"10.1177\/0883073813487595","volume":"28","author":"SA Masino","year":"2013","unstructured":"Masino SA, Ruskin DN. Ketogenic diets and pain. J Child Neurol. 2013;28(8):993\u20131001. https:\/\/doi.org\/10.1177\/0883073813487595.","journal-title":"J Child Neurol"},{"issue":"4","key":"8583_CR47","doi-asserted-by":"publisher","first-page":"847","DOI":"10.1016\/j.cll.2006.07.006","volume":"26","author":"EJ Jeyarajah","year":"2006","unstructured":"Jeyarajah EJ, Cromwell WC, Otvos JD. Lipoprotein particle analysis by nuclear magnetic resonance spectroscopy. Clin Lab Med. 2006;26(4):847\u201370. https:\/\/doi.org\/10.1016\/j.cll.2006.07.006.","journal-title":"Clin Lab Med"},{"issue":"4","key":"8583_CR48","doi-asserted-by":"publisher","first-page":"305","DOI":"10.1097\/MOL.0b013e32833b7756","volume":"21","author":"RM Krauss","year":"2010","unstructured":"Krauss RM. Lipoprotein subfractions and cardiovascular disease risk. Curr Opin Lipidol. 2010;21(4):305\u201311. https:\/\/doi.org\/10.1097\/MOL.0b013e32833b7756.","journal-title":"Curr Opin Lipidol"},{"issue":"3","key":"8583_CR49","doi-asserted-by":"publisher","first-page":"342","DOI":"10.1007\/s12603-016-0753-7","volume":"21","author":"JC Brown","year":"2017","unstructured":"Brown JC, Harhay MO, Harhay MN. Appendicular lean mass and mortality among prefrail and frail older adults. J Nutr Health Aging. 2017;21(3):342\u20135. https:\/\/doi.org\/10.1007\/s12603-016-0753-7.","journal-title":"J Nutr Health Aging"},{"issue":"2","key":"8583_CR50","doi-asserted-by":"publisher","DOI":"10.1177\/2055102918788195","volume":"5","author":"S Williams","year":"2018","unstructured":"Williams S, Sheffield D, Knibb RC. The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL): development and preliminary validation. Health Psychol Open. 2018;5(2): 2055102918788195. https:\/\/doi.org\/10.1177\/2055102918788195.","journal-title":"Health Psychol Open"},{"issue":"1","key":"8583_CR51","doi-asserted-by":"publisher","first-page":"43","DOI":"10.1111\/j.1468-3083.2010.03685.x","volume":"25","author":"B Dr\u00e9no","year":"2011","unstructured":"Dr\u00e9no B, Poli F, Pawin H, et al. Development and evaluation of a Global Acne Severity Scale (GEA Scale) suitable for France and Europe. J Eur Acad Dermatol Venereol. 2011;25(1):43\u20138. https:\/\/doi.org\/10.1111\/j.1468-3083.2010.03685.x.","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"11","key":"8583_CR52","doi-asserted-by":"publisher","first-page":"1440","DOI":"10.1210\/jcem-21-11-1440","volume":"21","author":"D Ferriman","year":"1961","unstructured":"Ferriman D, Gallwey JD. Clinical assessment of body hair growth in women. J Clin Endocrinol Metab. 1961;21(11):1440\u20137. https:\/\/doi.org\/10.1210\/jcem-21-11-1440.","journal-title":"J Clin Endocrinol Metab"},{"issue":"11","key":"8583_CR53","doi-asserted-by":"publisher","first-page":"1179","DOI":"10.1016\/j.jclinepi.2010.04.011","volume":"63","author":"D Cella","year":"2010","unstructured":"Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005\u20132008. J Clin Epidemiol. 2010;63(11):1179\u201394. https:\/\/doi.org\/10.1016\/j.jclinepi.2010.04.011.","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"8583_CR54","doi-asserted-by":"publisher","first-page":"233","DOI":"10.1016\/0149-7189(82)90074-x","volume":"5","author":"CC Attkisson","year":"1982","unstructured":"Attkisson CC, Zwick R. The client satisfaction questionnaire: psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233\u20137. https:\/\/doi.org\/10.1016\/0149-7189(82)90074-x.","journal-title":"Eval Program Plann"},{"issue":"10","key":"8583_CR55","doi-asserted-by":"publisher","first-page":"1749","DOI":"10.1001\/archinte.1987.00370100063012","volume":"147","author":"RR Wing","year":"1987","unstructured":"Wing RR, Koeske R, Epstein LH, Nowalk MP, Gooding W, Becker D. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med. 1987;147(10):1749\u201353.","journal-title":"Arch Intern Med"},{"issue":"1","key":"8583_CR56","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1186\/s12978-024-01758-5","volume":"21","author":"AE Juh\u00e1sz","year":"2024","unstructured":"Juh\u00e1sz AE, Stubnya MP, Teutsch B, et al. Ranking the dietary interventions by their effectiveness in the management of polycystic ovary syndrome: a systematic review and network meta-analysis. Reprod Health. 2024;21(1):28. https:\/\/doi.org\/10.1186\/s12978-024-01758-5.","journal-title":"Reprod Health"},{"issue":"3","key":"8583_CR57","doi-asserted-by":"publisher","first-page":"173","DOI":"10.3109\/09513590903215581","volume":"26","author":"C Fux Otta","year":"2010","unstructured":"Fux Otta C, Wior M, Iraci GS, et al. Clinical, metabolic, and endocrine parameters in response to metformin and lifestyle intervention in women with polycystic ovary syndrome: a randomized, double-blind, and placebo control trial. Gynecol Endocrinol. 2010;26(3):173\u20138. https:\/\/doi.org\/10.3109\/09513590903215581.","journal-title":"Gynecol Endocrinol"},{"issue":"1","key":"8583_CR58","doi-asserted-by":"publisher","first-page":"83","DOI":"10.3945\/ajcn.2010.29261","volume":"92","author":"KA Marsh","year":"2010","unstructured":"Marsh KA, Steinbeck KS, Atkinson FS, Petocz P, Brand-Miller JC. Effect of a low glycemic index compared with a conventional healthy diet on polycystic ovary syndrome. Am J Clin Nutr. 2010;92(1):83\u201392. https:\/\/doi.org\/10.3945\/ajcn.2010.29261.","journal-title":"Am J Clin Nutr"},{"key":"8583_CR59","doi-asserted-by":"crossref","unstructured":"Diggle PJ, Heagerty P, Liang K-Y, Zeger S. Analysis of longitudinal data. 2nd ed.\u00a0Oxford: Oxford University Press; 2002.","DOI":"10.1093\/oso\/9780198524847.001.0001"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08583-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08583-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08583-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T02:01:46Z","timestamp":1731117706000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08583-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,9]]},"references-count":59,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8583"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08583-y","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,9]]},"assertion":[{"value":"5 August 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 October 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 November 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This trial uses a single institutional review board, and the main application was approved by the University of Michigan Medicine Institutional Review Board on April 27th, 2022 (HUM00210749). The study team will review the main consent document in full with each participant and answer questions. They will inform the participant that participation is optional, and they are free to leave the study at any time.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"All participants in the trial provide informed, written consent using institutional review board-approved consent forms. The authors will provide a model consent form upon request.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"Dr. Saslow received funding from Sentinel Management, Milken Foundation, and the Baszucki Brain Research Fund to support research on the impact of a ketogenic diet for severe mental illness. Dr. Saslow\u2019s partner, H.B., is an inventor of software used in this study, which purchased a software services agreement for its use. The other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"750"}}