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

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

The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve (including premature ovarian insufficiency).

Study Overview

• Status: Recruiting
• Conditions: Diminished Ovarian Reserve; Premature Ovarian Insufficiency
• Intervention / Treatment: Dietary supplement: NMN intervention; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Jie Qiao, Ph.D.; Phone Number: +86 010-82265080; Email: jie.qiao@263.net
      • Principal Investigator: Jie Qiao, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMN intervention; 3 months of NMN	Dietary supplement: NMN intervention; NMN capsules (total of 600mg/day) for 3 months
Placebo Comparator: Placebo; 3 months of NMN-free placebo	Other: Placebo; NMN-free placebo capsules for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after 2, 8, 12 weeks of intervention
The alterations of gut metabolites	Determination the alterations of gut metabolites before and after NMN intervention by metabolomics.	before and after 2, 8, 12 weeks of intervention
Blood sugar level	Changes in plasma glucose concentration after the intervention.	before and after 2, 8, 12 weeks of intervention
Fasting insulin	Changes in plasma insulin concentration after the intervention.	before and after 2, 8, 12 weeks of intervention
Endocrine hormones including AMH	Changes in endocrine hormones including AMH levels in serum after the intervention.	before and after 3 months 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 3 months 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 3 months of intervention
Blood NAD+ level	Changes in whole blood NAD+ level after the intervention.	before and after 2, 8, 12 weeks of intervention
Changes in NAD-related metabolites in urine	Determination the changes of NAD-related metabolites in urine before and after NMN intervention by metabolomics.	before and after 2, 8, 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: M2022262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Patients' information is requested to be confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No