Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Placebo; Dietary Supplement: NMN intervention

• Registration Number: NCT05305677
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-06-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	8 weeks of NMN-free placebo
NMN intervention	NMN intervention	8 weeks of NMN

Primary Outcome Measures

Name	Time	Method
Glucose tolerance	before and after 8 weeks of intervention	Measure glucose tolerance by 75 g oral glucose tolerance test.
Gut microbiota	before and after 8 weeks of intervention	Study the gut microbiota change of stool samples between placebo group and intervention group.
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.
Metabolomics	before and after 8 weeks of intervention	Change of metabolomics profiles before and after NMN intervention.
Changes in blood NAD+ level	before and after 2, 4, 8 weeks of intervention
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.
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.

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure	before and after 2, 4, 8 weeks of intervention
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 body mass index	before and after 2, 4, 8 weeks of intervention	BMI measured with the formula BMI=weight \[kg\]/height² \[m\].

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China