Nicotinamide Riboside and Metabolic Health

March 20, 2019 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nicotinamide Riboside
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.
Dietary supplement: Placebo
Dietary supplement: Nicotinamide Riboside (Niagen)
PLACEBO_COMPARATOR: Placebo
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.
Dietary supplement: Placebo
Dietary supplement: Nicotinamide Riboside (Niagen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks after supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mitochondrial function (ex vivo)
Time Frame: 6 weeks after supplementation
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.
6 weeks after supplementation
Ectopic lipid accumulation
Time Frame: 6 weeks after supplementation
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
6 weeks after supplementation
Brown adipose tissue activity
Time Frame: 6 weeks after supplementation
Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
6 weeks after supplementation
Cardiovascular risk parameters
Time Frame: 6 weeks after supplementation
Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
6 weeks after supplementation
Whole body energy expenditure
Time Frame: 6 weeks after supplementation

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).
6 weeks after supplementation
Body composition
Time Frame: 6 weeks after supplementation
Fat mass and fat free mass measured with a BodPod.
6 weeks after supplementation
Acetylcarnitine levels
Time Frame: 6 weeks after supplementation
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
6 weeks after supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Dutch Heart Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL58119.068.16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe