Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05305677

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to understand the effect of Nicotinamide mononucleotide (NMN) on patients with polycystic ovary syndrome.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: NMN intervention Other: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NMN intervention 8 weeks of NMN	Dietary Supplement: NMN intervention NMN capsules (total of 600mg/day) for 8 weeks
Placebo Comparator: Placebo 8 weeks of NMN-free placebo	Other: Placebo NMN-free placebo capsules for 8 weeks

Arm

Intervention/Treatment

Experimental: NMN intervention

8 weeks of NMN

Dietary Supplement: NMN intervention

NMN capsules (total of 600mg/day) for 8 weeks

Placebo Comparator: Placebo

8 weeks of NMN-free placebo

Other: Placebo

NMN-free placebo capsules for 8 weeks

Outcome Measures

Primary Outcome Measures

Gut microbiota [before and after 8 weeks of intervention]
Study the gut microbiota change of stool samples between placebo group and intervention group.
Metabolomics [before and after 8 weeks of intervention]
Change of metabolomics profiles before and after NMN intervention.
Glucose tolerance [before and after 8 weeks of intervention]
Measure glucose tolerance by 75 g oral glucose tolerance test.
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index [before and after 2, 4, 8 weeks of intervention]
Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.
Endocrine hormones [before and after 2, 4, 8 weeks of intervention]
Changes in endocrine hormone levels in serum after intervention.
Ovarian volume [before and after 2, 4, 8 weeks of intervention]
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Follicle number [before and after 2, 4, 8 weeks of intervention]
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Changes in blood NAD+ level [before and after 2, 4, 8 weeks of intervention]

Secondary Outcome Measures

Changes in body mass index [before and after 2, 4, 8 weeks of intervention]
BMI measured with the formula BMI=weight [kg]/height² [m].
Changes in waist-to-hip ratio [before and after 2, 4, 8 weeks of intervention]
Calculated with the formula: waist circumference/hip circumference.
Changes in blood pressure [before and after 2, 4, 8 weeks of intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
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).
Individuals who can insist on continuous monitoring in the outpatient clinic.
Individuals who are not participating in other research projects currently or 3 months before the intervention.

Exclusion Criteria:

Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
Individuals who are during pregnant, lactation or menopause.
Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
A medical history of severe cardiovascular and cerebrovascular diseases.
Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
Individuals who drink more than 15g of alcohol per day or have a smoking habit.
Individuals who need drug treatment for any mental illness such as epilepsy and depression.
Cancer patients.
Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.