Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+)

NCT ID: NCT06005350

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

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The investigation is a clinical study in which the impact of taking the dietary supplement nicotinamide riboside (NR) on the concentration of extracellular nicotinamide adenine dinucleotide (eNAD+) in human plasma over time will be determined. The study will be conducted in a randomized, double-blinded, and placebo-controlled manner.

Detailed Description

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The significance of nicotinamide adenine dinucleotide (NAD+) in promoting a healthy life is currently under intense research. Despite an increasing number of research groups focusing on NAD+, there is no validated measurement method for extracellular NAD+. With this research project, the investigators aim to address this research gap.

The coenzyme NAD+ is one of the central regulators of metabolism, existing mostly in its oxidized form, NAD+, and its reduced form, NADH, in a dynamic equilibrium. NAD+ is indispensable for various metabolic processes, and is especially key in ATP generation. It also enables gluconeogenesis, ketogenesis, pentose phosphate production, heme and lipid synthesis, and the elimination of oxygen radicals.

To validate the NAD+ assay as a robust and reliable quantification method of extracellular NAD+, a controlled increase of the measured metabolite in blood plasma is required through NAD+ precursor administration.

Multiple studies have already demonstrated that oral NR intake can increase NAD+ levels in mammalian cells, rodent tissues, and peripheral blood mononuclear cells (PBMCs) in humans. However, this relationship has not been explored in the extracellular space due to the lack of reliable quantification of eNAD+ levels. Now, using the NAD+ assay, the investigators aim to examine the increase of eNAD+ after oral NR intake and provide initial data on the effects of a 1000 mg/day dosage.

Conditions

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NAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NR-Treatment

NR-Chloride Preparation 1000mg/day for 10 days

(500mg - 0 - 500mg -0)

Group Type EXPERIMENTAL

Niagen

Intervention Type DIETARY_SUPPLEMENT

Nicotinamide-Riboside-Chloride Preparation 1000mg/day

Placebo

Placebo for 10 days

(1 - 0 - 1 - 0)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Preperation

Interventions

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Niagen

Nicotinamide-Riboside-Chloride Preparation 1000mg/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo Preperation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Good general health
* Normal nutritional status and
* Age \>18 years.

Exclusion Criteria

* Pregnancy and/or lactation, or
* Severe psychiatric disorders, or
* Conditions that involve attention deficits, or
* Severe medical conditions, or
* Withdrawal of consent by the participant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ChromaDex, Inc.

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Felix Krenzien

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Surgical Clinic, Campus Virchow-Klinikum / Campus Charité Mitte, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Bogan KL, Brenner C. Nicotinic acid, nicotinamide, and nicotinamide riboside: a molecular evaluation of NAD+ precursor vitamins in human nutrition. Annu Rev Nutr. 2008;28:115-30. doi: 10.1146/annurev.nutr.28.061807.155443.

Reference Type BACKGROUND
PMID: 18429699 (View on PubMed)

Brunnbauer P, Leder A, Kamali C, Kamali K, Keshi E, Splith K, Wabitsch S, Haber P, Atanasov G, Feldbrugge L, Sauer IM, Pratschke J, Schmelzle M, Krenzien F. The nanomolar sensing of nicotinamide adenine dinucleotide in human plasma using a cycling assay in albumin modified simulated body fluids. Sci Rep. 2018 Oct 31;8(1):16110. doi: 10.1038/s41598-018-34350-6.

Reference Type BACKGROUND
PMID: 30382125 (View on PubMed)

Canto C, Houtkooper RH, Pirinen E, Youn DY, Oosterveer MH, Cen Y, Fernandez-Marcos PJ, Yamamoto H, Andreux PA, Cettour-Rose P, Gademann K, Rinsch C, Schoonjans K, Sauve AA, Auwerx J. The NAD(+) precursor nicotinamide riboside enhances oxidative metabolism and protects against high-fat diet-induced obesity. Cell Metab. 2012 Jun 6;15(6):838-47. doi: 10.1016/j.cmet.2012.04.022.

Reference Type BACKGROUND
PMID: 22682224 (View on PubMed)

Chi Y, Sauve AA. Nicotinamide riboside, a trace nutrient in foods, is a vitamin B3 with effects on energy metabolism and neuroprotection. Curr Opin Clin Nutr Metab Care. 2013 Nov;16(6):657-61. doi: 10.1097/MCO.0b013e32836510c0.

Reference Type BACKGROUND
PMID: 24071780 (View on PubMed)

Dolopikou CF, Kourtzidis IA, Margaritelis NV, Vrabas IS, Koidou I, Kyparos A, Theodorou AA, Paschalis V, Nikolaidis MG. Acute nicotinamide riboside supplementation improves redox homeostasis and exercise performance in old individuals: a double-blind cross-over study. Eur J Nutr. 2020 Mar;59(2):505-515. doi: 10.1007/s00394-019-01919-4. Epub 2019 Feb 6.

Reference Type BACKGROUND
PMID: 30725213 (View on PubMed)

Imai SI, Guarente L. It takes two to tango: NAD+ and sirtuins in aging/longevity control. NPJ Aging Mech Dis. 2016 Aug 18;2:16017. doi: 10.1038/npjamd.2016.17. eCollection 2016.

Reference Type BACKGROUND
PMID: 28721271 (View on PubMed)

Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.

Reference Type BACKGROUND
PMID: 27721479 (View on PubMed)

Yoshino J, Baur JA, Imai SI. NAD+ Intermediates: The Biology and Therapeutic Potential of NMN and NR. Cell Metab. 2018 Mar 6;27(3):513-528. doi: 10.1016/j.cmet.2017.11.002. Epub 2017 Dec 14.

Reference Type BACKGROUND
PMID: 29249689 (View on PubMed)

Other Identifiers

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EA4/210/19

Identifier Type: -

Identifier Source: org_study_id

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