Role of the Ketogenic Diet in Women With PCOS

NCT04175964 | Unknown

• 1 other identifier: ketogenic diet in PCOS
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

• Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.

  To evaluate the role of the ketogenic diet in overweight and obese women with PCOS regarding ovulation that will be assessed by serial transvaginal ultrasound.

  8 weeks

• comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.

  comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.

  8 weeks

Secondary Outcomes (2)

• Role of the ketogenic diet in the affection of testosterone level

  8 weeks

• comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level

  8 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

PCO patients that will receive ketogenic diet only

Behavioral: ketogenic diet

Group 2

EXPERIMENTAL

PCO patients that will receive caloric diet with Metformin

Combination Product: caloric diet with Metformin

Group 3

EXPERIMENTAL

PCO patients that will receive caloric diet only

Behavioral: caloric diet

Interventions

ketogenic diet BEHAVIORAL

The ketogenic diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.

Group 1

caloric diet with Metformin COMBINATION_PRODUCT

The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet with Metformin for 8 weeks.

Group 2

caloric diet BEHAVIORAL

The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.

Group 3

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age range between 16-35 years.
• BMI ≥ 27.
• Normal Renal Function.
• Rotterdam criteria for the diagnosis of polycystic ovary syndrome:
• Oligo/anovulation
• Hyperandrogenism
• Polycystic ovaries on ultrasound.

You may not qualify if:

• Age \<16 or \>35 years.
• BMI \< 27.
• Pregnancy.
• Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia
• Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Related Publications (3)

• 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

• Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.

  PMID: 18158291 BACKGROUND

• Moran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9. doi: 10.1210/jc.2002-020815.

  PMID: 12574218 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet, Ketogenic; Metformin; Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals; Energy Intake

Study Officials

• Amr Abbassy, MD

  National Research Centre, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mazen Abdel Rasheed, PhD

CONTACT

+201111242366; doctor_mazen@hotmail.com

Amr Abbassy, MD

CONTACT

+201001446860; abbassy2002@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Principal Investigator

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10