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Nicotinamide Riboside and Metabolic Health

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Nicotinamide Riboside (Niagen)
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Nicotinamide Riboside, Obesity, Metabolic health, Insulin resistance, Mitochondrial function, Brown adipose tissue, Energy expenditure, Ectopic lipid accumulation, Cardiovascular risk, Acetylcarnitine

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nicotinamide Riboside

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Insulin sensitivity: muscle- and liver specific
Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.

Secondary Outcome Measures

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.
Ectopic lipid accumulation
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Brown adipose tissue activity
Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Cardiovascular risk parameters
Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
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).
Body composition
Fat mass and fat free mass measured with a BodPod.
Acetylcarnitine levels
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

Full Information

First Posted
July 8, 2016
Last Updated
March 20, 2019
Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02835664
Brief Title
Nicotinamide Riboside and Metabolic Health
Official Title
Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dutch Heart Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Nicotinamide Riboside, Obesity, Metabolic health, Insulin resistance, Mitochondrial function, Brown adipose tissue, Energy expenditure, Ectopic lipid accumulation, Cardiovascular risk, Acetylcarnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotinamide Riboside
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide Riboside (Niagen)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Insulin sensitivity: muscle- and liver specific
Description
Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.
Time Frame
6 weeks after supplementation
Secondary Outcome Measure Information:
Title
Muscle mitochondrial function (ex vivo)
Description
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.
Time Frame
6 weeks after supplementation
Title
Ectopic lipid accumulation
Description
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Time Frame
6 weeks after supplementation
Title
Brown adipose tissue activity
Description
Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Time Frame
6 weeks after supplementation
Title
Cardiovascular risk parameters
Description
Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
Time Frame
6 weeks after supplementation
Title
Whole body energy expenditure
Description
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).
Time Frame
6 weeks after supplementation
Title
Body composition
Description
Fat mass and fat free mass measured with a BodPod.
Time Frame
6 weeks after supplementation
Title
Acetylcarnitine levels
Description
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
Time Frame
6 weeks after supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Schrauwen, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33524145
Citation
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.
Results Reference
derived
PubMed Identifier
32320006
Citation
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.
Results Reference
derived

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Nicotinamide Riboside and Metabolic Health

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