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Completed

NCT Number: NCT05305677

Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

NMN intervention

Dietary Supplement

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

Placebo

Other

NMN-free placebo capsules for 8 weeks

Primary outcomes

  1. Testosterone level

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes of testosterone level in serum after intervention.

  2. Antral follicle counts

    Time frame: 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.

  3. Menstrual cycle

    Time frame: before and after 8 weeks of intervention

    The changes of menstrual cycle frequency after intervention.

Secondary outcomes

  1. Luteinizing hormone (LH) level

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes of LH level in serum after intervention.

  2. Follicle-stimulating hormone (FSH) level

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes of FSH level in serum after intervention.

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

    Time frame: From enrollment to the end of treatment at 8 weeks

    Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.

  4. Changes in other endocrine hormones

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. Changes in blood NAD+ level and related metabolites

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. Multi-omics

    Time frame: From enrollment to the end of treatment at 8 weeks

    Collect samples before and after 2, 4, 8 weeks of intervention

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Acronym: NMN

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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