Ketogenic Diet in PCOS With Obesity and Insulin Resistance

NCT04801173 | Completed

• 1 other identifier: VLCKD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the VLCKD randomized clinical trial is to demonstrate the superiority of very low calorie ketogenic diet with respect to the standard low calorie diet in reducing body weight and insulin resistance in obese and insulin resistant patients with Polycystic Ovary Syndrome

Conditions

PCOS; Obesity; Insulin Resistance

Keywords

Ketogenic diet; Insulin resistance; PCOS; Obesity; Hyperandrogenism

Outcome Measures

Primary Outcomes (2)

• Change in Body mass index

  Weight and height will be combined to report BMI in kg/m\^2

  16 weeks after the start of treatment

• Change in body composition measured by bioimpedentiometry

  Fat mass and lean mass changes will be considered to estimate change in body composition and reported as %

  16 weeks after the start of the treatment

Secondary Outcomes (6)

• Change in Body mass index

  8 weeks after the start of treatment

• Change in body composition measured by bioimpedentiometry

  8 weeks after the start of the treatment

• Change in Homeostasis Model Assessment Index

  16 weeks after the start of the treatment

• Change in frequency of menstrual cycles

  16 weeks after the start of the treatment

• Change in hirsutism

  16 weeks after the start of the treatment

Study Arms (2)

Very low calorie ketogenic diet

EXPERIMENTAL

Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method

Combination Product: Very low calorie ketogenic diet; Behavioral: Low calorie standard diet

Low calorie diet

ACTIVE COMPARATOR

Control treatment with a low calorie standard diet

Behavioral: Low calorie standard diet

Interventions

Very low calorie ketogenic diet COMBINATION_PRODUCT

Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method

Also known as: Pronokal method

Very low calorie ketogenic diet

Low calorie standard diet BEHAVIORAL

Low calorie standard diet with no specified dietary supplement addition

Low calorie diet; Very low calorie ketogenic diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS according to the NIH criteria;
• Body mass index (BMI) between 30 and 35 kg/m3;
• HOMA index ≥ 3 (according to formula: (fasting glucose \[mmol/L\] × fasting insulin \[mIU/L\])/22.5)
• Written informed consent.

You may not qualify if:

• Diabetes type 1
• Exogenous insulin or insulin analogue therapy
• Obesity caused by endocrine disease other than PCOS
• Obesity caused by pharmacotherapy
• Use of a weight-loss diet in the past 3 months
• Use of contraceptive pills in the past 3 months
• Severe depression
• Other psychiatric diseases
• Alcohol or psychoactive substance abuse
• Severe hepatic insufficiency
• Renal calculosis
• Renal insufficiency
• Episodes of gout
• Malignant neoplasia
• Previous cardiovascular or cerebrovascular events

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Pronokal group: collaborator

Study Sites (1)

Unit of Endocrinology and Prevention and Care of Diabetes, S.Orsola Hospital

Bologna, 40138, Italy

Location

Related Publications (15)

• Tosi F, Bonora E, Moghetti P. Insulin resistance in a large cohort of women with polycystic ovary syndrome: a comparison between euglycaemic-hyperinsulinaemic clamp and surrogate indexes. Hum Reprod. 2017 Dec 1;32(12):2515-2521. doi: 10.1093/humrep/dex308.

  PMID: 29040529 BACKGROUND

• Conway G, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Franks S, Gambineri A, Kelestimur F, Macut D, Micic D, Pasquali R, Pfeifer M, Pignatelli D, Pugeat M, Yildiz BO; ESE PCOS Special Interest Group. The polycystic ovary syndrome: a position statement from the European Society of Endocrinology. Eur J Endocrinol. 2014 Oct;171(4):P1-29. doi: 10.1530/EJE-14-0253. Epub 2014 May 21.

  PMID: 24849517 BACKGROUND

• Repaci A, Gambineri A, Pasquali R. The role of low-grade inflammation in the polycystic ovary syndrome. Mol Cell Endocrinol. 2011 Mar 15;335(1):30-41. doi: 10.1016/j.mce.2010.08.002. Epub 2010 Aug 11.

  PMID: 20708064 BACKGROUND

• Barrea L, Marzullo P, Muscogiuri G, Di Somma C, Scacchi M, Orio F, Aimaretti G, Colao A, Savastano S. Source and amount of carbohydrate in the diet and inflammation in women with polycystic ovary syndrome. Nutr Res Rev. 2018 Dec;31(2):291-301. doi: 10.1017/S0954422418000136. Epub 2018 Jul 23.

  PMID: 30033891 BACKGROUND

• Gonzalez F. Nutrient-Induced Inflammation in Polycystic Ovary Syndrome: Role in the Development of Metabolic Aberration and Ovarian Dysfunction. Semin Reprod Med. 2015 Jul;33(4):276-86. doi: 10.1055/s-0035-1554918. Epub 2015 Jul 1.

  PMID: 26132932 BACKGROUND

• Volk KM, Pogrebna VV, Roberts JA, Zachry JE, Blythe SN, Toporikova N. High-Fat, High-Sugar Diet Disrupts the Preovulatory Hormone Surge and Induces Cystic Ovaries in Cycling Female Rats. J Endocr Soc. 2017 Nov 2;1(12):1488-1505. doi: 10.1210/js.2017-00305. eCollection 2017 Dec 1.

  PMID: 29308444 BACKGROUND

• Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.

  PMID: 30052961 BACKGROUND

• Matsuzaki T, Douchi T, Oki T, Ishihara O, Okagaki R, Kajihara T, Tamura M, Kotsuji F, Tajima K, Kawano M, Ishizuka B, Irahara M. Weight reduction using a formula diet recovers menstruation in obese patients with an ovulatory disorder. Reprod Med Biol. 2017 Jul 7;16(3):268-275. doi: 10.1002/rmb2.12034. eCollection 2017 Jul.

  PMID: 29259477 BACKGROUND

• Mehrabani HH, Salehpour S, Amiri Z, Farahani SJ, Meyer BJ, Tahbaz F. Beneficial effects of a high-protein, low-glycemic-load hypocaloric diet in overweight and obese women with polycystic ovary syndrome: a randomized controlled intervention study. J Am Coll Nutr. 2012 Apr;31(2):117-25. doi: 10.1080/07315724.2012.10720017.

  PMID: 22855917 BACKGROUND

• Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.

  PMID: 25527677 BACKGROUND

• 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 Dec 16;2:35. doi: 10.1186/1743-7075-2-35.

  PMID: 16359551 BACKGROUND

• Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.

  PMID: 31111407 BACKGROUND

• Costello MF, Misso ML, Balen A, Boyle J, Devoto L, Garad RM, Hart R, Johnson L, Jordan C, Legro RS, Norman RJ, Mocanu E, Qiao J, Rodgers RJ, Rombauts L, Tassone EC, Thangaratinam S, Vanky E, Teede HJ; International PCOS Network. Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: assessment and treatment of infertility. Hum Reprod Open. 2019 Jan 4;2019(1):hoy021. doi: 10.1093/hropen/hoy021. eCollection 2019.

  PMID: 31486807 BACKGROUND

• Moreno B, Bellido D, Sajoux I, Goday A, Saavedra D, Crujeiras AB, Casanueva FF. Comparison of a very low-calorie-ketogenic diet with a standard low-calorie diet in the treatment of obesity. Endocrine. 2014 Dec;47(3):793-805. doi: 10.1007/s12020-014-0192-3. Epub 2014 Mar 4.

  PMID: 24584583 BACKGROUND

• Goday A, Bellido D, Sajoux I, Crujeiras AB, Burguera B, Garcia-Luna PP, Oleaga A, Moreno B, Casanueva FF. Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Nutr Diabetes. 2016 Sep 19;6(9):e230. doi: 10.1038/nutd.2016.36.

  PMID: 27643725 BACKGROUND

MeSH Terms

Conditions

Obesity; Insulin Resistance; Hyperandrogenism

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 16, 2021
• Study Start: March 2, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

IT (1)