Nicotinamide Riboside and Metabolic Health

NCT ID: NCT02835664

Last Updated: 2019-03-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.

Detailed Description

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Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nicotinamide Riboside

Supplementation of Nicotinamide Riboside (Niagen) of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.

Group Type EXPERIMENTAL

Nicotinamide Riboside (Niagen)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Supplementation of Placebo of 1000 mg/day for 6 weeks. 2 capsules in the morning together with breakfast and 2 capsules around noon together with lunch. Each capsule contains 250 mg.

Group Type PLACEBO_COMPARATOR

Nicotinamide Riboside (Niagen)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nicotinamide Riboside (Niagen)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Caucasian
* Males and postmenopausal females
* Aged 45-65 years at start of the study
* Body mass index (BMI) 27 - 35 kg/m2
* Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)
* Sedentary lifestyle (not more than 2 hours of sports per week)

Exclusion Criteria

* Type 2 diabetes
* Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
* Contra-indication for MRI
* Participation in earlier research or medical examination that included PET/CT scanning
* Alcohol consumption of \>2 servings per day
* Smoking in the past 6 months
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dutch Heart Foundation

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Schrauwen, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Centre

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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Nascimento EBM, Moonen MPB, Remie CME, Gariani K, Jorgensen JA, Schaart G, Hoeks J, Auwerx J, van Marken Lichtenbelt WD, Schrauwen P. Nicotinamide Riboside Enhances In Vitro Beta-adrenergic Brown Adipose Tissue Activity in Humans. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1437-1447. doi: 10.1210/clinem/dgaa960.

Reference Type DERIVED
PMID: 33524145 (View on PubMed)

Remie CME, Roumans KHM, Moonen MPB, Connell NJ, Havekes B, Mevenkamp J, Lindeboom L, de Wit VHW, van de Weijer T, Aarts SABM, Lutgens E, Schomakers BV, Elfrink HL, Zapata-Perez R, Houtkooper RH, Auwerx J, Hoeks J, Schrauwen-Hinderling VB, Phielix E, Schrauwen P. Nicotinamide riboside supplementation alters body composition and skeletal muscle acetylcarnitine concentrations in healthy obese humans. Am J Clin Nutr. 2020 Aug 1;112(2):413-426. doi: 10.1093/ajcn/nqaa072.

Reference Type DERIVED
PMID: 32320006 (View on PubMed)

Other Identifiers

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NL58119.068.16

Identifier Type: -

Identifier Source: org_study_id

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