ObesityNCT02835664
Nicotinamide Riboside and Metabolic Health
A study testing Nicotinamide Riboside (Niagen) in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Nicotinamide Riboside (Niagen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2016to Dec 2018
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans
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.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Nicotinamide Riboside (Niagen), Placebo
- Keywords
- Nicotinamide Riboside, Obesity, Metabolic health, Insulin resistance, Mitochondrial function, Brown adipose tissue, Energy expenditure, Ectopic lipid accumulation, Cardiovascular risk, Acetylcarnitine
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (Niagen)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Nicotinamide Riboside (Niagen); Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity: muscle- and liver specific
Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.
Measured: 6 weeks after supplementation
Secondary outcomes (7)
Muscle mitochondrial function (ex vivo)
Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.
Measured: 6 weeks after supplementation
Ectopic lipid accumulation
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Measured: 6 weeks after supplementation
Brown adipose tissue activity
Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Measured: 6 weeks after supplementation
Cardiovascular risk parameters
Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
Measured: 6 weeks after supplementation
Whole body energy expenditure
Sleeping metabolic rate measured during an overnight stay in a respiration chamber.
Resting metabolic rate measured with ventilated hood system, basal, during insulin stimulation (clamp) and during cold stimulation (cooling protocol BAT activity).
Measured: 6 weeks after supplementation
Body composition
Fat mass and fat free mass measured with a BodPod.
Measured: 6 weeks after supplementation
Acetylcarnitine levels
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
Measured: 6 weeks after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Patrick Schrauwen, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835664
- Sponsor's protocol ID
- NL58119.068.16
- Status last verified
- Apr 2018
- First submitted
- 8 Jul 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33524145Remie 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.
PubMed 32320006
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans
- ClinicalTrials.gov ID
- NCT02835664
- Acronym / sponsor ID
- NL58119.068.16
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Nicotinamide Riboside, Obesity, Metabolic health, Insulin resistance, Mitochondrial function, Brown adipose tissue, Energy expenditure, Ectopic lipid accumulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 18 Jul 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside | Experimental | Dietary Supplement: Nicotinamide Riboside (Niagen), Dietary Supplement: PlaceboSupplementation 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. |
| Placebo | Placebo comparator | Dietary Supplement: Nicotinamide Riboside (Niagen), Dietary Supplement: PlaceboSupplementation 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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) | Dietary supplement | Nicotinamide Riboside, Placebo |
| Placebo | Dietary supplement | Nicotinamide Riboside, Placebo |
Primary outcome
Insulin sensitivity: muscle- and liver specific
Time frame: 6 weeks after supplementation
Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.
7 secondary outcomes
Muscle mitochondrial function (ex vivo)
Time frame: 6 weeks after supplementation
Ectopic lipid accumulation
Time frame: 6 weeks after supplementation
Brown adipose tissue activity
Time frame: 6 weeks after supplementation
Cardiovascular risk parameters
Time frame: 6 weeks after supplementation
Whole body energy expenditure
Time frame: 6 weeks after supplementation
Body composition
Time frame: 6 weeks after supplementation
Acetylcarnitine levels
Time frame: 6 weeks after supplementation
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 22 Mar 2019.
- Derived from this study: PubMed 33524145Nascimento 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.
- Derived from this study: PubMed 32320006Remie 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.
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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.
Patrick Schrauwen, PhD principal investigator
Maastricht University Medical Center
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) in people with Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 inclusion and 6 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 22 Mar 2019. 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 Netherlands. 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: muscle- and liver specific (time frame: 6 weeks after supplementation). 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 NCT02835664, which also lists 2 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 22 Mar 2019.