An open, prospective controlled trial to access the alteration of the intest and mouth microbe with the intervention of the low carbohydrates but high-protein dietary in POCS patients

An open, prospective controlled trial to access the alteration of the intest and mouth microbe with the intervention of the high-protein but low carbohydrate diatery in POCS patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034480

Enrollment

Unknown

Registered

2020-07-06

Start date

2020-08-01

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

polycystic ovaries

Interventions

non-PCOS group:no intervention

PCOS group:low carbohydrates but high-protein dietary

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for polycystic ovary syndrome (see Appendix 1 for diagnostic criteria); (2) 18-year-old female <= 50-year-old female; (3) 25 <= BMI <= 40kg/m2; (4) Those who have not participated in any clinical research and are willing to participate in this research.

Exclusion criteria

Exclusion criteria: (1) People with diabetes and abnormal heart, liver, and kidney functions have infectious diseases or other serious organic diseases such as cancer, myocardial infarction, and stroke; (2) Any active infection, liver or kidney disease, or any other chronic comorbidities; (3) Use metformin, thiazolidinediones, any hormonal drugs including estrogen and progesterone, antibiotics, probiotics, laxatives or choline or carnitine containing supplements within the previous 3 months, or surgery to lose weight By; (4) Patients with chronic gastrointestinal diseases such as chronic gastritis and enteritis; (5) Other diseases that lead to increased androgen levels or ovulation disorders, including congenital adrenal hyperplasia, androgen-secreting tumors, premature ovarian failure, pituitary or hypothalamic amenorrhea, and abnormal thyroid function; (6) Smoking, alcoholism, severe mental illness in the past 6 months, etc.; (7) People with anemia: Hemoglobin <110g/L; (8) Can not guarantee sufficient time to participate in this project.

Design outcomes

Primary

Measure	Time frame
The alterations of the microbial abundance for oral cavity and intestinal tract;	—

Secondary

Measure	Time frame
Changes in patient weight, blood lipids, liver function, uric acid, and kidney function;Changes in ovarian volume, number of follicles and menstrual cycle;Changes in total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulfate in patients;;Changes in patients' blood glucose, blood insulin levels, and insulin resistance index;	—

Countries

China

Contacts

Public ContactGao Bin

Endocrinology Department, Tangdu Hospital

8823317@qq.com+86 13772100470

Outcome results

None listed

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