Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome (NMN)

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

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: NMN intervention; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone level	Changes of testosterone level in serum after intervention.	From enrollment to the end of treatment at 8 weeks
Antral follicle counts	The number of antral follicle counts in each ovary will be determined using transvaginal ultrasonography for each participant.	From enrollment to the end of treatment at 8 weeks
Menstrual cycle	The changes of menstrual cycle frequency after intervention.	before and after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Luteinizing hormone (LH) level	Changes of LH level in serum after intervention.	From enrollment to the end of treatment at 8 weeks
Follicle-stimulating hormone (FSH) level	Changes of FSH level in serum after intervention.	From enrollment to the end of treatment at 8 weeks
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index	Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.	From enrollment to the end of treatment at 8 weeks
Changes in other endocrine hormones		From enrollment to the end of treatment at 8 weeks
Changes in blood NAD+ level and related metabolites		From enrollment to the end of treatment at 8 weeks
Multi-omics	Collect samples before and after 2, 4, 8 weeks of intervention	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; metabolism; gut microbiota; reproductive endocrine; NMN
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: M2021577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients' information is requested to be confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No