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TerminatedNCT03310034NADSUpdated Aug 20, 2020

NAD Supplementation Study

An interventional study of NAD-precursors and Control in Aging and Mitochondrial Function, sponsored by Maastricht University. Terminated at 1 site in Netherlands. Open to participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Maastricht University · Not applicable, Interventional, and Basic science

Why this study was terminated
Concluded study following COVID19 outbreak and inability to complete study as designed.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aging
  • Mitochondrial Function
03

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    Intervention

    Dietary Supplement: NAD-precursors

  • Placebo comparator
    Control

    Dietary Supplement: Control

Interventions

  • Dietary supplementNAD-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.

  • Dietary supplementControl

    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.

05

What researchers measure

Primary outcomes

  1. Ex vivo mitochondrial respiration

    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: After 4 weeks of supplementation.

  2. Basal metabolic rate

    Basal metabolic rate expressed as kcal/kg/min

    Time frame: After 4 weeks of supplementation.

  3. In vivo mitochondrial capacity

    In vivo mitochondrial capacity measured with 31P-MRS.

    Time frame: After 4 weeks of supplementation.

  4. Submaximal exercise energy expenditure

    Submaximal exercise energy expenditure expressed as kcal/kg/min

    Time frame: After 4 weeks of supplementation.

Secondary outcomes

  1. Glucose tolerance

    Glucose tolerance measured by oral glucose tolerance test.

    Time frame: After 4 weeks of supplementation.

  2. Ectopic lipid accumulation

    Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.

    Time frame: After 4 weeks of supplementation.

  3. Acetylcarnitine levels

    Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).

    Time frame: After 4 weeks of supplementation.

  4. Physical function

    Measured by Short Physical Performance Battery and Frailty criteria.

    Time frame: After 4 weeks of supplementation.

06

Study locations

1 site
  • Maastricht University
    Maastricht, Limburg 6229ER, Netherlands
07

References and documents

Publications

  • Connell NJ, Grevendonk L, Fealy CE, Moonen-Kornips E, Bruls YMH, Schrauwen-Hinderling VB, de Vogel J, Hageman R, Geurts J, Zapata-Perez R, Houtkooper RH, Havekes B, Hoeks J, Schrauwen P. NAD+-Precursor Supplementation With L-Tryptophan, Nicotinic Acid, and Nicotinamide Does Not Affect Mitochondrial Function or Skeletal Muscle Function in Physically Compromised Older Adults. J Nutr. 2021 Oct 1;151(10):2917-2931. doi: 10.1093/jn/nxab193. PubMed 34191033 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03310034
Lead sponsor
Maastricht University
Responsible party
Patrick Schrauwen (Prof. Dr. P. Schrauwen, Maastricht University) — Principal investigator
First posted
Oct 16, 2017
Start date
Nov 1, 2017
Primary completion
Mar 6, 2020
Completion
Mar 6, 2020
Last update
Aug 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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