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

Diminished Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485610
• Other study ID #: M2022262
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Menopause, Premature
• Premature Birth
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

Dietary Supplement:
• NMN intervention
NMN capsules (total of 600mg/day) for 3 months

Other:
• Placebo
NMN-free placebo capsules for 3 months

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood sugar level	Changes in plasma glucose concentration after the intervention.	before and after 2, 8, 12 weeks of intervention
Primary	Fasting insulin	Changes in plasma insulin concentration after the intervention.	before and after 2, 8, 12 weeks of intervention
Primary	Endocrine hormones including AMH	Changes in endocrine hormones including AMH levels in serum after the intervention.	before and after 3 months of intervention
Primary	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
Primary	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
Primary	Blood NAD+ level	Changes in whole blood NAD+ level after the intervention.	before and after 2, 8, 12 weeks of intervention
Primary	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