Effect of Oral NAD+ Precursors Administration on Blood NAD+ Concentration in Healthy Adults

Healthy Clinical Trial

Official title:

Effect of Oral NAD+ Precursors Administration on Blood NAD+ Concentration in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05517122
• Other study ID #: 2201NR
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nicotinamide adenine dinucleotide (NAD) is a coenzyme playing a central role in human metabolic pathways. A recognized approach to increase NAD level is through oral supplementation of its precursors promoting NAD synthesis in vivo. NAD precursors exist in multiple forms. However, it is unclear how the various precursors compare in their ability to increase NAD levels in human blood. The purpose of this study is to compare the effect of 3 NAD precursors on whole blood NAD metabolome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy male and female aged 18-50 years, inclusive, at enrolment

2. Body mass index (BMI) between 18.5 to 27.0 kg/m².

3. Able to understand and to sign a written informed consent prior to study enrolment.

4. Willing and able to comply with the requirements for participation in this study.

Exclusion Criteria:

1. Known history of allergy or intolerance to the investigational products.

2. Any chronic medical condition and/or history of significant medical condition, which in the opinion of the site physician/ investigator may risk participant wellbeing/ safety, impede participant compliance with study procedures or ability to complete the study and/ or could confound the primary objectives of the study.

3. Any acute illness or any recent medical intervention including vaccination within 14 days before the first dose of investigational product.

4. Female participants who are pregnant or intending to become pregnant, lactating and/or breastfeeding. Women of childbearing potential who are not currently using medically effective forms of contraception.

5. Use of prescription drugs known to potentially interact with NAD precursors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.

6. Use of multivitamin/ multimineral supplements, NAD+ precursor supplementation (e.g., niacin, nicotinic acid or niacinamide), L-tryptophan supplementation and/ or any over-the- counter (OTC) medication promoting "healthy aging" or "anti-aging" or "longevity" up to 30 days before first dose of investigational product.

7. On a self-restricted diet, controlled diet or special therapeutic diet up to 30 days before first dose of investigational product.

8. Average alcohol consumption greater than 2 standard drinks per day over a week for males, and greater than 1 standard drink per day over a week for females. One standard drink contains 10-12 g of ethanol. Examples of standard drinks are one beer can (300 ml), one glass of wine (100 ml) or one glass of schnaps (30 ml).

9. Current smoker (e.g., cigarette, tobacco, cannabis) who exceeds 5 cigarettes per week.

10. Performing shift work or trans-meridian travel greater than two time zones within 14 days prior to the first dose of investigational product.

11. Currently participating in another research study.

12. Family or hierarchical relationships with the Clinical Innovation Lab (CIL) team.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Nicotinamide (NAM)
500 mg a day
• Nicotinamide Riboside (NR)
1000 mg a day
• Nicotinamide Mono Nucleotide (NMN)
1000 mg a day
• Microcrystalline cellulose
500 mg a day

Locations

Country	Name	City	State
Switzerland	Nestlé Clinical Innovation Lab	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparer the extend the NAD+ precursors (NAM, NR and NMN) affect the NAD+ metabolome in in plasma.	Measure the change in plasma NAD+ metabolites iAUC (reported in microM) and Cmax (microM) determined by quantitative liquid chromatography-mass spectroscopy	over 4 hours at Day 1 and at Day 14.
Other	Comparer the extend the NAD+ precursors (NAM, NR and NMN) affect the NAD+ metabolome in urine	Measure the change in urine NAD+ metabolites iAUC (reported in microM) and Cmax (microM) determined by quantitative liquid chromatography-mass spectroscopy	at baseline Day 14 versus Day 1
Primary	Determine the extent of increase in NAD+ level in whole blood, for each NAD+ precursor (NAM, NR and NMN) compared to placebo	Measure the changes in whole blood NAD+ level interventions vs placebo: NAM vs placebo, NR vs placebo, NMN versus placebo by quantitative liquid chromatography-mass spectroscopy	at Day 14
Primary	Compare the extent of increase in NAD+ level in whole blood across the 3 NAD+ precursors (NAM, NR and NMN)	Measure the changes in whole blood NAD+ level across interventions: NAM vs NR, NAM vs NMN, NR vs NMN by quantitative liquid chromatography-mass spectroscopy	at Day 14
Secondary	Determine the extent the NAD+ precursors(NAM, NR and NMN) affect the NAD metabolome in whole blood compared to placebo	Measure the change in whole blood NAD+ metabolites iAUC (reported as microM*h) and Cmax (microM) by quantitative liquid chromatography-mass spectroscopy	over 4 hours at Day 1 and at Day 14.
Secondary	Compare the extent the NAD+ precursors (NAM, NR and NMN) affect the NAD+ metabolome in whole blood.	Measure the change in whole blood NAD+ metabolites iAUC (reported as microM*h) and Cmax (microM) determined by quantitative liquid chromatography-mass spectroscopy	over 4 hours at Day 1 and at Day 14.