ObeseNCT02303483
The Effect of Vitamin B3 on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men
A study testing Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ) in people with Obese, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2016to 4 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written signed consent
- male
- BMI>30 kg/(m2)
- age: 40-70
- no medication
- non-smoker
Who cannot join
- endocrine disease
- other severe disease
- high daily activity level (>30 min / day)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Laboratories, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: The Effect of Nicotinamide Ribose (NR) on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men - a Randomized, Placebo Controlled Clinical Trial
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.
- Conditions
- Obese
- Being tested
- Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ), Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | lime tablets Receives: Dietary Supplement: Placebo |
| Nicotinamide riboside (NR, Vit B3) | Experimental | NIAGEN (ChromaDex) 1 g x 2 orally per day Receives: Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
determined by a hyperinsulineamic clamp
Measured: Change from baseline in insulin sensitivity at 3 months
Secondary outcomes (9)
Substrate metabolism
measured by indirect calorimetry
Measured: Change from baseline in substrate metabolism at 3 months
body composition
measured by DEXA scan
Measured: Change from baseline in body composition at 3 months
Activation of satellite cells
measured by immunohistochemestry
Measured: Change from baseline in activation of satellite cells at 3 months
lipid accumulation in liver and skeletal muscle tissue
determined by MR-spectroscopy
Measured: Change from baseline in liver and muscle lipid content at 3 months
glucose turnover
determined by glucose tracer techniques
Measured: Change from baseline in glucose turnover at 3 months
insulin signalling in skeletal muscle and adipose tissue biopsies
western blotting
Measured: Change from baseline in insulin signaling at 3 months
Palmitate turnover
determined by palmitate tracer techniques
Measured: Change from baseline in palmitate turnover at 3 months
Gut microbiota
Intestinal bacteria composition by whole genome sequencing
Measured: Change from baseline in composition of gut microbiota at 3 months
Incretin hormone secretion
Determined by measurement of incretin homones during an oral glucose tolerance test (OGTT)
Measured: Change from baseline in incretion hormone secretion at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study start4 Jan 2016
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Ole Dollerup, Aarhus University Hospital
- Investigators
- Ole Dollerup, MD, Principal investigator, The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303483
- Sponsor's protocol ID
- 44081
- Status last verified
- Jun 2017
- First submitted
- 20 Nov 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31710095Dollerup 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.
PubMed 31390002Dollerup 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.
PubMed 29992272
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicotinamide Ribose (NR) on Substrate Metabolism, Insulin Sensitivity, and Body Composition in Obese Men - a Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02303483
- Acronym / sponsor ID
- 44081
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebolime tablets |
| Nicotinamide riboside (NR, Vit B3) | Experimental | Dietary Supplement: Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )NIAGEN (ChromaDex) 1 g x 2 orally per day |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written signed consent
- male
- BMI>30 kg/(m2)
- age: 40-70
- no medication
Key exclusion criteria (3 listed)
- endocrine disease
- other severe disease
- high daily activity level (>30 min / day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ) | Dietary supplement | Nicotinamide riboside (NR, Vit B3) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Insulin sensitivity
Time frame: Change from baseline in insulin sensitivity at 3 months
determined by a hyperinsulineamic clamp
9 secondary outcomes
Substrate metabolism
Time frame: Change from baseline in substrate metabolism at 3 months
body composition
Time frame: Change from baseline in body composition at 3 months
Activation of satellite cells
Time frame: Change from baseline in activation of satellite cells at 3 months
lipid accumulation in liver and skeletal muscle tissue
Time frame: Change from baseline in liver and muscle lipid content at 3 months
glucose turnover
Time frame: Change from baseline in glucose turnover at 3 months
insulin signalling in skeletal muscle and adipose tissue biopsies
Time frame: Change from baseline in insulin signaling at 3 months
Palmitate turnover
Time frame: Change from baseline in palmitate turnover at 3 months
Gut microbiota
Time frame: Change from baseline in composition of gut microbiota at 3 months
Incretin hormone secretion
Time frame: Change from baseline in incretion hormone secretion at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 31710095Dollerup 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.
- Derived from this study: PubMed 31390002Dollerup 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.
- Derived from this study: PubMed 29992272Dollerup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Dollerup, MD principal investigator
The Novo Nordisk Foundation Center for Basic Metabolic Research, Integrative Physiology, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA ) in people with Obese, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Change from baseline in insulin sensitivity at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303483, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.