NAD Supplementation Study

NCT03310034 | Terminated

• 1 other identifier: NL61204.068.17
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Mitochondrial Function

Outcome Measures

Primary Outcomes (4)

• 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.

  After 4 weeks of supplementation.

• Basal metabolic rate

  Basal metabolic rate expressed as kcal/kg/min

  After 4 weeks of supplementation.

• In vivo mitochondrial capacity

  In vivo mitochondrial capacity measured with 31P-MRS.

  After 4 weeks of supplementation.

• Submaximal exercise energy expenditure

  Submaximal exercise energy expenditure expressed as kcal/kg/min

  After 4 weeks of supplementation.

Secondary Outcomes (4)

• Glucose tolerance

  After 4 weeks of supplementation.

• Ectopic lipid accumulation

  After 4 weeks of supplementation.

• Acetylcarnitine levels

  After 4 weeks of supplementation.

• Physical function

  After 4 weeks of supplementation.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Dietary Supplement: NAD-precursors

Control

PLACEBO COMPARATOR

Dietary Supplement: Control

Interventions

NAD-precursors DIETARY_SUPPLEMENT

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.

Intervention

Control DIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34191033 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P. Schrauwen

Model Details: Randomized, dubbel-blind, cross-over trial

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: November 1, 2017
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)