Nicotinamide Riboside and Metabolic Health

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02835664

Collaborator

Dutch Heart Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Dietary Supplement: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Nicotinamide Riboside on Metabolic Health in (Pre)Obese Humans

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo
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: Nicotinamide Riboside (Niagen) Dietary Supplement: Placebo

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: Nicotinamide Riboside (Niagen)

Dietary Supplement: Placebo

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: Nicotinamide Riboside (Niagen)

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

Insulin sensitivity: muscle- and liver specific [6 weeks after supplementation]
Hyperinsulinemic euglycemic clamp: Rate of glucose disappearance (Rd) will be calculated by using tracer kinetics.

Secondary Outcome Measures

Muscle mitochondrial function (ex vivo) [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.
Ectopic lipid accumulation [6 weeks after supplementation]
Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Brown adipose tissue activity [6 weeks after supplementation]
Subjects will be exposed to an individualized cooling protocol, after which an 18F-FDG PET/CT scan is made
Cardiovascular risk parameters [6 weeks after supplementation]
Cardiac energy status measured with P-MRS and Ambulatory blood pressure.
Whole body energy expenditure [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).
Body composition [6 weeks after supplementation]
Fat mass and fat free mass measured with a BodPod.
Acetylcarnitine levels [6 weeks after supplementation]
Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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