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NAD Supplementation Study (NADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03310034
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : September 11, 2019
Information provided by (Responsible Party):
Patrick Schrauwen, Maastricht University

Brief Summary:
This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.

Condition or disease Intervention/treatment Phase
Aging Mitochondrial Function Dietary Supplement: NAD-precursors Dietary Supplement: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Nadide

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. Basal metabolic rate [ Time Frame: After 4 weeks of supplementation. ]
    Basal metabolic rate expressed as kcal/kg/min

  3. In vivo mitochondrial capacity [ Time Frame: After 4 weeks of supplementation. ]
    In vivo mitochondrial capacity measured with 31P-MRS.

  4. Submaximal exercise energy expenditure [ Time Frame: After 4 weeks of supplementation. ]
    Submaximal exercise energy expenditure expressed as kcal/kg/min

Secondary Outcome Measures :
  1. Glucose tolerance [ Time Frame: After 4 weeks of supplementation. ]
    Glucose tolerance measured by oral glucose tolerance test.

  2. Ectopic lipid accumulation [ Time Frame: After 4 weeks of supplementation. ]
    Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.

  3. 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).

  4. Physical function [ Time Frame: After 4 weeks of supplementation. ]
    Measured by Short Physical Performance Battery and Frailty criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and females
  • Age ≥ 65 ≤ 75 years;
  • BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
  • Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;
  • SPPB score 4-9 and (pre-)frail;
  • Subject should be in sufficient health to participate in the experiments, to be judged by the responsible physician based on the subject's medical history.

Exclusion Criteria:

  • Not meeting all inclusion criteria;
  • Smoking;
  • Excessive alcohol use and/or drug abuse;
  • Subjects with diabetes mellitus type 2;
  • Significant food allergies or intolerances concerning the study products;
  • Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
  • Medication use known to hamper subject's safety during the study procedures;
  • Subjects who use selective serotonin re-uptake inhibitors (SSRI), or selective norepinephrin re-uptake inhibitors (SNRI), or monoamino oxidase inhibitors (MAO-inhibitors), or clomipramine, or St. John's wort (Hypericum perforatum);
  • Subjects with contra-indications for MRI;
  • Subjects who do not want to be informed about unexpected medical findings;
  • Subjects who do not want that their treating physician to be informed;
  • Co-morbidities to which the intervention or program the may pose as a complicating factor;
  • Inability to participate and/or complete the required measurements.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03310034

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Contact: Niels Connell, MSc 0031 43 3881587
Contact: Patrick Schrauwen, PhD 0031 43 3881502

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Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6229ER
Contact: Niels Connell, MSc    +31433881587   
Sponsors and Collaborators
Maastricht University
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Responsible Party: Patrick Schrauwen, Prof. Dr. P. Schrauwen, Maastricht University Identifier: NCT03310034    
Other Study ID Numbers: NL61204.068.17
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No