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Comparative Effects of Ketogenic Diet versus Mediterranean Diet on Insulin Resistance and Menstrual Regularity in Women with PCOS: A Randomized Controlled Trial

Comparative Effects of Ketogenic Diet versus Mediterranean Diet on Insulin Resistance and Menstrual Regularity in Women with PCOS: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122054
Enrollment
Unknown
Registered
2026-04-08
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

Test group:ketogenic diet
control group:Mediterranean diet

Sponsors

Yangzhou Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age: 16-45 years old, female. 2. Diagnostic criteria: PCOS that meets the Rotterdam criteria for diagnosis in 2003 - Infrequent ovulation or anovulation (menstrual cycle >35 days or less than 8 menstruation per year) - Clinical and/or biochemical hyperandrogenemia - Ultrasound shows polycystic changes in the ovaries (antral follicle count >=12 on one or both ovaries, and/or ovarian volume >10mL) - At least two of the above three items are met, and other diseases causing similar manifestations are excluded. 3. BMI: >=24 kg/m² (overweight or obese) 4. Informed consent: Voluntary participation and signing of the informed consent form (consent from a guardian is required for those under 18 years old). 5. Compliance: Be able to carry out dietary intervention as required by the research and conduct regular follow-ups

Exclusion criteria

Exclusion criteria: 1.Endocrine diseases: uncontrolled thyroid dysfunction, Cushing's syndrome, hyperprolactinemia, congenital adrenal hyperplasia, etc. 2. Metabolic diseases: Diabetes, severe liver and kidney dysfunction (ALT/AST >3 times the upper limit of normal, Cr >133 µmol/L) 3. Cardiovascular diseases: Severe cardiovascular diseases, uncontrolled hypertension (SBP>=160 or DBP>=100 mmHg) 4. Other diseases: Active infections, malignant tumors, mental disorders, eating disorders. 5. Medication history: Used hormone drugs, insulin sensitizers (such as metformin), and weight loss drugs in the past 3 months. 6. Dietary taboos: Allergy to the components of the studied diet. 7. Pregnancy and lactation: Pregnancy and lactation. 8. Other interventions: Participated in other dietary intervention studies in the past three months

Design outcomes

Primary

MeasureTime frame
homeostatic model assessment for insulin resistance;Regularity of menstruation (regular/irregular, or changes in the number of days in the cycle);

Secondary

MeasureTime frame
Anthropometric indicators;Reproductive endocrine indicators;Lipid metabolism indicators;

Countries

China

Contacts

Public ContactMin Wang

Yangzhou Maternal and Child Health Care Hospital

wmin725@163.com+86 151 9042 6367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026