NAD Supplementation Study

Not Applicable

Terminated

• Conditions: Aging; Mitochondrial Function
• Interventions: Dietary Supplement: NAD-precursors; Dietary Supplement: Control

• Registration Number: NCT03310034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-16
• Study Start: 2017-11-01
• Status Verified: 2020-03
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-06
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	NAD-precursors	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Submaximal exercise energy expenditure	After 4 weeks of supplementation.	Submaximal exercise energy expenditure expressed as kcal/kg/min
Ex vivo mitochondrial respiration	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	After 4 weeks of supplementation.	Basal metabolic rate expressed as kcal/kg/min
In vivo mitochondrial capacity	After 4 weeks of supplementation.	In vivo mitochondrial capacity measured with 31P-MRS.

Secondary Outcome Measures

Name	Time	Method
Ectopic lipid accumulation	After 4 weeks of supplementation.	Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.
Glucose tolerance	After 4 weeks of supplementation.	Glucose tolerance measured by oral glucose tolerance test.
Acetylcarnitine levels	After 4 weeks of supplementation.	Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).
Physical function	After 4 weeks of supplementation.	Measured by Short Physical Performance Battery and Frailty criteria.

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands