Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

NCT05305677 | Completed DMC

• 1 other identifier: M2021577
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndrome; reproductive endocrine; metabolism; gut microbiota; NMN

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Luteinizing hormone (LH) level

  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

• Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index

  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

Study Arms (2)

NMN intervention

EXPERIMENTAL

8 weeks of NMN

Dietary Supplement: NMN intervention

Placebo

PLACEBO COMPARATOR

8 weeks of NMN-free placebo

Other: Placebo

Interventions

NMN intervention DIETARY_SUPPLEMENT

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

NMN intervention

Placebo OTHER

NMN-free placebo capsules for 8 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who are 20 to 40 years old;
• BMI \< 25 kg/m2;
• 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.

You may not qualify if:

• 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 B-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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 31, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)