NAD Supplementation Study

Aging Clinical Trial

— NADS  

Official title:

The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03310034
• Other study ID #: NL61204.068.17
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: March 6, 2020

Study information

• Verified date: March 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Mitochondrial Function

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Basal metabolic rate	Basal metabolic rate expressed as kcal/kg/min	After 4 weeks of supplementation.
Primary	In vivo mitochondrial capacity	In vivo mitochondrial capacity measured with 31P-MRS.	After 4 weeks of supplementation.
Primary	Submaximal exercise energy expenditure	Submaximal exercise energy expenditure expressed as kcal/kg/min	After 4 weeks of supplementation.
Secondary	Glucose tolerance	Glucose tolerance measured by oral glucose tolerance test.	After 4 weeks of supplementation.
Secondary	Ectopic lipid accumulation	Liver and skeletal muscle lipid accumulation measured with H-MRS in vivo.	After 4 weeks of supplementation.
Secondary	Acetylcarnitine levels	Skeletal muscle acetylcarnitine levels measured with H-MRS in vivo, before and after exercise stimulation (cycling).	After 4 weeks of supplementation.
Secondary	Physical function	Measured by Short Physical Performance Battery and Frailty criteria.	After 4 weeks of supplementation.