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Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)

Primary Purpose

Diminished Ovarian Reserve, Premature Ovarian Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NMN intervention
Placebo
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diminished Ovarian Reserve

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals who are 20 to 40 years old.
  2. The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations of day-3 follicle-stimulating hormone (FSH) ≥10 IU/L.
  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 are during pregnant, lactation or menopause.
  2. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.
  3. Individuals who had pelvic surgery.
  4. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.
  5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
  6. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
  7. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months.
  8. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months.
  9. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 months.
  10. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
  11. A medical history of severe cardiovascular and cerebrovascular diseases.
  12. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
  13. Individuals who drink more than 15g of alcohol per day or have a smoking habit.
  14. Individuals who need drug treatment for any mental illness such as epilepsy and depression.
  15. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
  16. Unable or unwilling to follow the study protocol.

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

3 months of NMN

3 months of NMN-free placebo

Outcomes

Primary Outcome Measures

The comparison of the gut microbiota composition
Determination the gut microbiota composition change of stool samples between placebo group and intervention group by 16S metagenomic.
The alterations of gut metabolites
Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.
Blood sugar level
Changes in plasma glucose concentration after the intervention.
Fasting insulin
Changes in plasma insulin concentration after the intervention.
Endocrine hormones including AMH
Changes in endocrine hormones including AMH levels in serum after the 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.
Blood NAD+ level
Changes in whole blood NAD+ level after the intervention.
Changes in NAD-related metabolites in urine
Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2022
Last Updated
October 9, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05485610
Brief Title
Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
Official Title
Effect of NMN (Nicotinamide Mononucleotide) Intervention on Patients With Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (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 diminished ovarian reserve (including premature ovarian insufficiency).
Detailed Description
This study aims to evaluate the effects of NMN on reproductive endocrine, immune homeostasis, and reproductive outcomes in women with DOR (including POI), and to explore its underlying mechanisms to provide the intervention strategies for DOR (including POI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diminished Ovarian Reserve, Premature Ovarian Insufficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMN intervention
Arm Type
Experimental
Arm Description
3 months of NMN
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 months of NMN-free placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
NMN intervention
Intervention Description
NMN capsules (total of 600mg/day) for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
NMN-free placebo capsules for 3 months
Primary Outcome Measure Information:
Title
The comparison of the gut microbiota composition
Description
Determination the gut microbiota composition change of stool samples between placebo group and intervention group by 16S metagenomic.
Time Frame
before and after 2, 8, 12 weeks of intervention
Title
The alterations of gut metabolites
Description
Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.
Time Frame
before and after 2, 8, 12 weeks of intervention
Title
Blood sugar level
Description
Changes in plasma glucose concentration after the intervention.
Time Frame
before and after 2, 8, 12 weeks of intervention
Title
Fasting insulin
Description
Changes in plasma insulin concentration after the intervention.
Time Frame
before and after 2, 8, 12 weeks of intervention
Title
Endocrine hormones including AMH
Description
Changes in endocrine hormones including AMH levels in serum after the intervention.
Time Frame
before and after 3 months 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 3 months 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 3 months of intervention
Title
Blood NAD+ level
Description
Changes in whole blood NAD+ level after the intervention.
Time Frame
before and after 2, 8, 12 weeks of intervention
Title
Changes in NAD-related metabolites in urine
Description
Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.
Time Frame
before and after 2, 8, 12 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. The concentrations of anti-Mullerian hormone < 1.1 ng/ml, the values of antral follicle count range from less than 5 to less than 7 and two recordings of serum concentrations of day-3 follicle-stimulating hormone (FSH) ≥10 IU/L. 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 are during pregnant, lactation or menopause. Individuals who had non-46-XX karyotype, or attributed to known genetic etiology. Individuals who had pelvic surgery. Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. Use of medications or traditional Chinese medicine that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 3 months. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation, or other supplementation such as coenzyme Q10, vitamin E currently or within the past 3 months. Use of antibiotics, probiotics, or prebiotics that affect the flora within the past 3 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. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc. Unable or unwilling to follow the study protocol.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, Ph.D.
Phone
+86 010-82265080
Email
jie.qiao@263.net
First Name & Middle Initial & Last Name & Degree
Jie Qiao, Ph.D.

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 Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency)

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