Clinical trial NCT03310034: NAD Supplementation Study
Official title: The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Mitochondrial Function
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, dubbel-blind, cross-over trial
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ex vivo mitochondrial respiration
timeFrame: After 4 weeks of supplementation.
measure: Basal metabolic rate
timeFrame: After 4 weeks of supplementation.
measure: In vivo mitochondrial capacity
timeFrame: After 4 weeks of supplementation.
measure: Submaximal exercise energy expenditure
timeFrame: After 4 weeks of supplementation.
Secondary outcomes:
measure: Glucose tolerance
timeFrame: After 4 weeks of supplementation.
measure: Ectopic lipid accumulation
timeFrame: After 4 weeks of supplementation.
measure: Acetylcarnitine levels
timeFrame: After 4 weeks of supplementation.
measure: Physical function
timeFrame: After 4 weeks of supplementation.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: 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.