Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome

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

Detailed Description
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: NMN intervention
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who are 20 to 40 years old, planning to become pregnant or infertile women. 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). 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 B3-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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMN intervention<br>8 weeks of NMN | Dietary Supplement: NMN intervention<br>* NMN capsules (total of 600mg/day) for 8 weeks<br>|
| Placebo Comparator: Placebo<br>8 weeks of NMN-free placebo | Other: Placebo<br>* NMN-free placebo capsules for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota | Study the gut microbiota change of stool samples between placebo group and intervention group. | before and after 8 weeks of intervention | 
| Metabolomics | Change of metabolomics profiles before and after NMN intervention. | before and after 8 weeks of intervention | 
| Glucose tolerance | Measure glucose tolerance by 75 g oral glucose tolerance test. | before and after 8 weeks of intervention | 
| 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 | 
| Endocrine hormones | Changes in endocrine hormone levels in serum after intervention. | before and after 2, 4, 8 weeks of intervention | 
| 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 | 
| 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 | 
| Changes in blood NAD+ level |  | before and after 2, 4, 8 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body mass index | BMI measured with the formula BMI=weight [kg]/height² [m]. | before and after 2, 4, 8 weeks of intervention | 
| Changes in waist-to-hip ratio | Calculated with the formula: waist circumference/hip circumference. | before and after 2, 4, 8 weeks of intervention | 
| Changes in blood pressure |  | before and after 2, 4, 8 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN