The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men

NCT ID: NCT02303483

Last Updated: 2017-07-02

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-04

Study Completion Date

2017-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

lime tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Nicotinamide riboside (NR, Vit B3)

NIAGEN (ChromaDex) 1 g x 2 orally per day

Group Type EXPERIMENTAL

Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* endocrine disease
* other severe disease
* high daily activity level (\>30 min / day)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ole Dollerup

MD, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole Dollerup, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical Research Laboratories, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31710095 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31390002 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29992272 (View on PubMed)

Other Identifiers

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44081

Identifier Type: -

Identifier Source: org_study_id

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