NCT02303483

Brief Summary

In animals, treatment with vitamin B3 improved insulin sensitivity and substrate metabolism. It is currently not know if vitamin B3 has the same positive effects in humans. In the current study the effect of a 3 month treatment with vitamin B3 on insulin sensitivity and substrate metabolism in obese men will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

November 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

November 20, 2014

Last Update Submit

June 29, 2017

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    determined by a hyperinsulineamic clamp

    Change from baseline in insulin sensitivity at 3 months

Secondary Outcomes (9)

  • Substrate metabolism

    Change from baseline in substrate metabolism at 3 months

  • body composition

    Change from baseline in body composition at 3 months

  • Activation of satellite cells

    Change from baseline in activation of satellite cells at 3 months

  • lipid accumulation in liver and skeletal muscle tissue

    Change from baseline in liver and muscle lipid content at 3 months

  • glucose turnover

    Change from baseline in glucose turnover at 3 months

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

lime tablets

Dietary Supplement: Placebo

Nicotinamide riboside (NR, Vit B3)

EXPERIMENTAL

NIAGEN (ChromaDex) 1 g x 2 orally per day

Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

Interventions

Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )DIETARY_SUPPLEMENT
Nicotinamide riboside (NR, Vit B3)
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written signed consent
  • male
  • BMI\>30 kg/(m2)
  • age: 40-70
  • no medication
  • non-smoker

You may not qualify if:

  • endocrine disease
  • other severe disease
  • high daily activity level (\>30 min / day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Laboratories, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Dollerup OL, Chubanava S, Agerholm M, Sondergard SD, Altintas A, Moller AB, Hoyer KF, Ringgaard S, Stodkilde-Jorgensen H, Lavery GG, Barres R, Larsen S, Prats C, Jessen N, Treebak JT. Nicotinamide riboside does not alter mitochondrial respiration, content or morphology in skeletal muscle from obese and insulin-resistant men. J Physiol. 2020 Feb;598(4):731-754. doi: 10.1113/JP278752. Epub 2019 Dec 26.

    PMID: 31710095DERIVED

  • Dollerup OL, Trammell SAJ, Hartmann B, Holst JJ, Christensen B, Moller N, Gillum MP, Treebak JT, Jessen N. Effects of Nicotinamide Riboside on Endocrine Pancreatic Function and Incretin Hormones in Nondiabetic Men With Obesity. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5703-5714. doi: 10.1210/jc.2019-01081.

    PMID: 31390002DERIVED

  • Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, Stodkilde-Jorgensen H, Moller N, Brenner C, Treebak JT, Jessen N. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018 Aug 1;108(2):343-353. doi: 10.1093/ajcn/nqy132.

    PMID: 29992272DERIVED

MeSH Terms

Conditions

Obesity

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ole Dollerup, MD

    The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-student

Study Record Dates

First Submitted

November 20, 2014

First Posted

December 1, 2014

Study Start

January 4, 2016

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

DK(1)