Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

— NMN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305677
• Other study ID #: M2021577
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• NMN intervention
NMN capsules (total of 600mg/day) for 8 weeks

Other:
• Placebo
NMN-free placebo capsules for 8 weeks

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	Study the gut microbiota change of stool samples between placebo group and intervention group.	before and after 8 weeks of intervention
Primary	Metabolomics	Change of metabolomics profiles before and after NMN intervention.	before and after 8 weeks of intervention
Primary	Glucose tolerance	Measure glucose tolerance by 75 g oral glucose tolerance test.	before and after 8 weeks of intervention
Primary	Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index	Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.	before and after 2, 4, 8 weeks of intervention
Primary	Endocrine hormones	Changes in endocrine hormone levels in serum after intervention.	before and after 2, 4, 8 weeks of intervention
Primary	Ovarian volume	The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.	before and after 2, 4, 8 weeks of intervention
Primary	Follicle number	The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.	before and after 2, 4, 8 weeks of intervention
Primary	Changes in blood NAD+ level		before and after 2, 4, 8 weeks of intervention
Secondary	Changes in body mass index	BMI measured with the formula BMI=weight [kg]/height² [m].	before and after 2, 4, 8 weeks of intervention
Secondary	Changes in waist-to-hip ratio	Calculated with the formula: waist circumference/hip circumference.	before and after 2, 4, 8 weeks of intervention
Secondary	Changes in blood pressure		before and after 2, 4, 8 weeks of intervention