Back to resultsEffect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome (NMN)
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NMN intervention
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN
Eligibility Criteria
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.
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NMN intervention
Placebo
Arm Description
8 weeks of NMN
8 weeks of NMN-free placebo
Outcomes
Primary Outcome Measures
Gut microbiota
Study the gut microbiota change of stool samples between placebo group and intervention group.
Metabolomics
Change of metabolomics profiles before and after NMN intervention.
Glucose tolerance
Measure glucose tolerance by 75 g oral glucose tolerance test.
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.
Endocrine hormones
Changes in endocrine hormone levels in serum after intervention.
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Changes in blood NAD+ level
Secondary Outcome Measures
Changes in body mass index
BMI measured with the formula BMI=weight [kg]/height² [m].
Changes in waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference.
Changes in blood pressure
Full Information
NCT ID
NCT05305677
First Posted
March 14, 2022
Last Updated
May 28, 2023
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05305677
Brief Title
Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome
Acronym
NMN
Official Title
Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
polycystic ovary syndrome, reproductive endocrine, metabolism, gut microbiota, NMN
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMN intervention
Arm Type
Experimental
Arm Description
8 weeks of NMN
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
8 weeks of NMN-free placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
NMN intervention
Intervention Description
NMN capsules (total of 600mg/day) for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
NMN-free placebo capsules for 8 weeks
Primary Outcome Measure Information:
Title
Gut microbiota
Description
Study the gut microbiota change of stool samples between placebo group and intervention group.
Time Frame
before and after 8 weeks of intervention
Title
Metabolomics
Description
Change of metabolomics profiles before and after NMN intervention.
Time Frame
before and after 8 weeks of intervention
Title
Glucose tolerance
Description
Measure glucose tolerance by 75 g oral glucose tolerance test.
Time Frame
before and after 8 weeks of intervention
Title
Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Description
Changes in HOMA-IR index (fasting insulin * fasting glucose/22.5) after intervention.
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Endocrine hormones
Description
Changes in endocrine hormone levels in serum after intervention.
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Ovarian volume
Description
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Follicle number
Description
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Changes in blood NAD+ level
Time Frame
before and after 2, 4, 8 weeks of intervention
Secondary Outcome Measure Information:
Title
Changes in body mass index
Description
BMI measured with the formula BMI=weight [kg]/height² [m].
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Changes in waist-to-hip ratio
Description
Calculated with the formula: waist circumference/hip circumference.
Time Frame
before and after 2, 4, 8 weeks of intervention
Title
Changes in blood pressure
Time Frame
before and after 2, 4, 8 weeks of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, PhD
Phone
+86 010-82265080
Email
jie.qiao@263.net
First Name & Middle Initial & Last Name & Degree
Jie Qiao, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patients' information is requested to be confidential.
Learn more about this trial
Effect of NMN (Nicotinamide Mononucleotide) on Polycystic Ovary Syndrome
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