Polycystic Ovary Syndrome
Conditions
Keywords
polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN
Brief summary
The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.
Detailed description
This study aims to evaluate the effects of NMN on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (PCOS), and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
Interventions
DIETARY_SUPPLEMENTNMN intervention
NMN capsules (total of 600mg/day) for 8 weeks
OTHERPlacebo
NMN-free placebo capsules for 8 weeks
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals who are 20 to 40 years old; 2. BMI \< 25 kg/m2; 3. Individuals with PCOS should meet all the Rotterdam diagnostic criteria: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome). 4. Individuals who can insist on continuous monitoring in the outpatient clinic. 5. Individuals who are not participating in other research projects currently or 3 months before the intervention.
Exclusion criteria
1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities. 2. Individuals who are during pregnant, lactation or menopause. 3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 4. Individuals who take niacin, nicotinamide, or other vitamin B-related supplementation currently or within the past 2 months. 5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months. 7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 8. A medical history of severe cardiovascular and cerebrovascular diseases. 9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 10. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 11. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 12. Cancer patients. 13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone level | From enrollment to the end of treatment at 8 weeks | Changes of testosterone level in serum after intervention. |
| Antral follicle counts | From enrollment to the end of treatment at 8 weeks | The number of antral follicle counts in each ovary will be determined using transvaginal ultrasonography for each participant. |
| Menstrual cycle | before and after 8 weeks of intervention | The changes of menstrual cycle frequency after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in other endocrine hormones | From enrollment to the end of treatment at 8 weeks | — |
| Luteinizing hormone (LH) level | From enrollment to the end of treatment at 8 weeks | Changes of LH level in serum after intervention. |
| Multi-omics | From enrollment to the end of treatment at 8 weeks | Collect samples before and after 2, 4, 8 weeks of intervention |
| Changes in blood NAD+ level and related metabolites | From enrollment to the end of treatment at 8 weeks | — |
| Follicle-stimulating hormone (FSH) level | From enrollment to the end of treatment at 8 weeks | Changes of FSH level in serum after intervention. |
| Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index | From enrollment to the end of treatment at 8 weeks | Changes in HOMA-IR index (fasting insulin \* fasting glucose/22.5) after intervention. |
Countries
China
Outcome results
None listed