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Nutrient metabolism and gut microbiota characteristics and weight loss in obese patients with polycystic ovary syndrome

Nutrient metabolism and gut microbiota characteristics and weight loss in obese patients with polycystic ovary syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054961
Enrollment
Unknown
Registered
2021-12-29
Start date
2018-08-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

polycystic ovary syndrome (PCOS)

Interventions

Group A:Limit energy balance to lose weight
Group B:High protein diet
Group C:High protein and high dietary fiber to lose weight

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age limit: aged >18 years and = 28 kg/m^2; or women with waist circumference >= 80 cm as overweight or central obesity; or PBF >= 30% as obese. Therefore, this subject uses BMI >= 24kg/m^2; or waist circumference >= 80cm; or body fat percentage >= 28%, and one of the above three indicators is obese (including overweight and obesity); The above three indicators are normal for non-obese type. 4. Have no clear history of adverse metabolic diseases in the past, have the ability to understand the weight loss program and voluntarily participate in the whole process of weight loss; and sign the informed consent. 5. Can tolerate a certain degree of hunger or as a maintenance effect after weight loss. 6. The patient is able to comply with the doctor's management; and use a condom for contraception during the 8 weeks of weight loss therapy.

Exclusion criteria

Exclusion criteria: 1. Previous chronic kidney disease (chronic glomeruli, nephritis, chronic renal insufficiency, diabetic nephropathy, systemic disease involving the kidney); 2. Previously diagnosed heart disease (coronary heart disease, rheumatic heart disease, cardiomyopathy, cardiac insufficiency) and cerebrovascular disease (cerebral hemorrhage, cerebral infarction); 3. Acute infectious diseases or chronic wasting diseases, such as tuberculosis infection, malignant tumor, HIV infection, etc.; 4. Thyroid disease under treatment (hyperthyroidism or hypothyroidism); 5. Serious liver diseases, such as cirrhosis, liver cancer; 6. Ongoing gout or acute gout attack; 7. Mental illness has cognitive impairment; 8. Patients with eating disorders (bulimia nervosa, anorexia); 9. Cannot contact the doctor through the Internet or by phone; 10. Participated in other clinical trials within 3 months before screening; 11. Those who have used antibiotics, probiotics, hormone drugs and other preparations that may affect the intestinal flora within the past 1 month.

Design outcomes

Primary

MeasureTime frame
Body weight;Body fat percentage;Muscle mass;Fat-free mass;Androgen;Luteinizing hormone;Follicle stimulating hormone;Albumin;Creatinine;Superoxide dismutase;Malondialdehyde;IL-6;TNF-a;Basal metabolic rate;

Countries

China

Contacts

Public ContactDou Pan, Guo Xiaohui

Peking University First Hospital

229686702@qq.com+86 13311390060

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026