NAD Supplementation Study

NCT ID: NCT03310034

Last Updated: 2020-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-03-06

Brief Summary

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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

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Conditions

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Aging Mitochondrial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, dubbel-blind, cross-over trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

NAD-precursors

Intervention Type 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.

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Patrick Schrauwen

Prof. Dr. P. Schrauwen

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 34191033 (View on PubMed)

Other Identifiers

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NL61204.068.17

Identifier Type: -

Identifier Source: org_study_id

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