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

NCT05485610 | Unknown DMC

• 1 other identifier: M2022262
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Diminished Ovarian Reserve; Premature Ovarian Insufficiency

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

NMN intervention

EXPERIMENTAL

3 months of NMN

Dietary Supplement: NMN intervention

Placebo

PLACEBO COMPARATOR

3 months of NMN-free placebo

Other: Placebo

Interventions

NMN intervention DIETARY_SUPPLEMENT

NMN capsules (total of 600mg/day) for 3 months

NMN intervention

Placebo OTHER

NMN-free placebo capsules for 3 months

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: August 3, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)