Clinical trial NCT05305677: Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome
Official title: Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
reproductive endocrine
metabolism
gut microbiota
NMN
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 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).
3. Individuals who can insist on continuous monitoring in the outpatient clinic.
4. 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 B3-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.

Primary outcomes:
measure: Gut microbiota
timeFrame: before and after 8 weeks of intervention
measure: Metabolomics
timeFrame: before and after 8 weeks of intervention
measure: Glucose tolerance
timeFrame: before and after 8 weeks of intervention
measure: Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Endocrine hormones
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Ovarian volume
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Follicle number
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Changes in blood NAD+ level
timeFrame: before and after 2, 4, 8 weeks of intervention
Secondary outcomes:
measure: Changes in body mass index
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Changes in waist-to-hip ratio
timeFrame: before and after 2, 4, 8 weeks of intervention
measure: Changes in blood pressure
timeFrame: before and after 2, 4, 8 weeks of intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: