Role of the Ketogenic Diet in Women With PCOS

NCT ID: NCT04175964

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-06-30

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.

Detailed Description

Polycystic ovary syndrome (PCOS) is one of the most common endocrinal abnormalities that affect females within the reproductive age, and are found in about 4% of women. PCOS is commonly associated with symptoms of increased testosterone such as irregular or absent menstrual cycle, increased body hair, and infertility. PCOS is also associated with other disorders such as obesity, insulin resistance, hyperinsulinemia, diabetes mellitus type 2, and dyslipidemia.

Until now, there is no known curative treatment for PCOS. However, anti-diabetic medications can improve many metabolic disorders such as insulin resistance, and increased levels of serum testosterone and total cholesterol. In addition, regulation of diet with exercise could improve the insulin sensitivity. Therefore, managements that aim to decrease the insulin level, improve the insulin resistance and decrease the body weight may be useful for improving symptoms of PCOS.

Ketogenic diets are characterized by a reduction in carbohydrates (usually to less than 50 g/day) and a relative increase in the proportions of protein and fat. People following the keto diet gain 75% of their calories from fat, 20% from protein, and 5% from carbohydrates. Previous studies have revealed that the ketogenic diet of low carbohydrate could decrease the body weight and improve the insulin resistance.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group 1

PCO patients that will receive ketogenic diet only

Group Type: EXPERIMENTAL

ketogenic diet

Intervention Type: 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 2

PCO patients that will receive caloric diet with Metformin

Group Type: EXPERIMENTAL

caloric diet with Metformin

Intervention Type: 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 3

PCO patients that will receive caloric diet only

Group Type: EXPERIMENTAL

caloric diet

Intervention Type: 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.

Interventions

ketogenic diet

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.

Intervention Type: BEHAVIORAL

caloric diet with Metformin

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.

Intervention Type: COMBINATION_PRODUCT

caloric diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age range between 16-35 years.

2. BMI ≥ 27.

3. Normal Renal Function.

4. Rotterdam criteria for the diagnosis of polycystic ovary syndrome:

• Oligo/anovulation
• Hyperandrogenism
• Polycystic ovaries on ultrasound.

Exclusion Criteria

1. Age <16 or >35 years.

2. BMI < 27.

3. Pregnancy.

4. Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia

5. Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Centre, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mazen Abdel Rasheed

Researcher, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Abbassy, MD

Role: STUDY_DIRECTOR

National Research Centre, Egypt

Central Contacts

Mazen Abdel Rasheed, PhD

Role: CONTACT

doctor_mazen@hotmail.com

+201111242366

Amr Abbassy, MD

Role: CONTACT

abbassy2002@hotmail.com

+201001446860

References

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.

Reference Type: BACKGROUND

PMID: 16359551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18158291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12574218 (View on PubMed)

Other Identifiers

ketogenic diet in PCOS

Identifier Type: -

Identifier Source: org_study_id