NCT02835664

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 22, 2019

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

July 8, 2016

Last Update Submit

March 20, 2019

Conditions

ObesityInsulin Resistance

Keywords

Nicotinamide RibosideObesityMetabolic healthInsulin resistanceMitochondrial functionBrown adipose tissueEnergy expenditureEctopic lipid accumulationCardiovascular riskAcetylcarnitine

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity: muscle- and liver specific

    Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.

    6 weeks after supplementation

Secondary Outcomes (7)

  • Muscle mitochondrial function (ex vivo)

    6 weeks after supplementation

  • Ectopic lipid accumulation

    6 weeks after supplementation

  • Brown adipose tissue activity

    6 weeks after supplementation

  • Cardiovascular risk parameters

    6 weeks after supplementation

  • Whole body energy expenditure

    6 weeks after supplementation

  • +2 more secondary outcomes

Study Arms (2)

Nicotinamide Riboside

EXPERIMENTAL

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.

Dietary Supplement: Nicotinamide Riboside (Niagen)Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Nicotinamide Riboside (Niagen)Dietary Supplement: Placebo

Interventions

Nicotinamide Riboside (Niagen)DIETARY_SUPPLEMENT
Nicotinamide RibosidePlacebo
PlaceboDIETARY_SUPPLEMENT
Nicotinamide RibosidePlacebo

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 33524145DERIVED

  • 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.

    PMID: 32320006DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Patrick Schrauwen, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 18, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 22, 2019

Record last verified: 2018-04

Locations

NL(1)