NAD Supplementation Study (NADS)
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|ClinicalTrials.gov Identifier: NCT03310034|
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aging Mitochondrial Function||Dietary Supplement: NAD-precursors Dietary Supplement: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Randomized, dubbel-blind, cross-over trial|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 31, 2020|
|Active Comparator: Intervention||
Dietary Supplement: NAD-precursors
Intervention product containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan (total of 204 NE per serving) in a whey protein source for 31 days.
|Placebo Comparator: Control||
Dietary Supplement: Control
Control product containing amino-acid mixture resembling whey-protein not containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan. To be taken for 31 days.
- Ex vivo mitochondrial respiration [ Time Frame: After 4 weeks of 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.
- Basal metabolic rate [ Time Frame: After 4 weeks of supplementation. ]Basal metabolic rate expressed as kcal/kg/min
- In vivo mitochondrial capacity [ Time Frame: After 4 weeks of supplementation. ]In vivo mitochondrial capacity measured with 31P-MRS.
- Submaximal exercise energy expenditure [ Time Frame: After 4 weeks of supplementation. ]Submaximal exercise energy expenditure expressed as kcal/kg/min
- Glucose tolerance [ Time Frame: After 4 weeks of supplementation. ]Glucose tolerance measured by oral glucose tolerance test.
- Ectopic lipid accumulation [ Time Frame: After 4 weeks of supplementation. ]Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
- Acetylcarnitine levels [ Time Frame: After 4 weeks of supplementation. ]Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
- Physical function [ Time Frame: After 4 weeks of supplementation. ]Measured by Short Physical Performance Battery and Frailty criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310034
|Contact: Niels Connell, MSc||0031 43 firstname.lastname@example.org|
|Contact: Patrick Schrauwen, PhD||0031 43 email@example.com|
|Maastricht, Limburg, Netherlands, 6229ER|
|Contact: Niels Connell, MSc +31433881587 firstname.lastname@example.org|