Nutritional Prevention of Exertional Muscle Dysfunction



Status:Completed
Conditions:Metabolic
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - 45
Updated:10/18/2017
Start Date:November 2012
End Date:August 2015

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The investigators want to find out whether a choline supplement can protect muscle health in
young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense
set of arm exercise and have a common genetic profile, will be asked to use a choline
supplement for three weeks and a placebo for three weeks. Before the begin of the
supplementation study and after 3 and 6 weeks the investigators will test response to the
exercise challenge and ask that all consumed foods are recorded.

An initial screening questionnaire will determine general eligibility. The investigators will
screen white young males with low to moderate choline intake (<450 mg/d) for CK response to
exercise (high/low) by having them do intense eccentric exercise (12 elbow flexor
contractions of non-dominant arm with dumbbell at 100% maximal lift capacity) and then 72
hours (3 days) later draw 250 μl capillary blood by finger stick for CK, metabolomic and
genetic measurements.

The investigators plan to recruit 30 CK responders with an 1958 A allele of the
methylenetetrahydrofolate dehydrogenase 1 (MTHFD1), which is present in about 60% of
Caucasian males.

All participants will be asked to complete on three days 24-hour diet interviews with an
online automated program provided by the National Cancer Institute. Participants of the
intervention study will also have to be complete interviews on the final three days of the
two intervention periods The recruited candidates will do an initial exercise challenge with
no intervention, then a second challenge after three weeks with the first supplement
(randomized choline or placebo), then a third challenge after another three weeks with the
complementary second supplement (choline if they had placebo first, placebo if they had
choline first).

Samples identified only by code will be stored indefinitely at the UNC Nutrition Research
Institute to permit the analysis of additional genetic markers related to muscle health and
choline metabolism when the capacity for the analysis of such markers becomes available. Such
analyses may be carried out at the University of North Carolina Nutrition Research Institute
(UNC NRI) or at external laboratories providing the service for the PI. Samples will be
destroyed once no such additional analyses are intended or feasible anymore or if the
investigators do not continue this research. Storage of the samples is not optional.

Inclusion Criteria:

- Caucasian

- choline intake less than 450 mg

- exertional muscle dysfunction

- susceptible genetic profile

Exclusion Criteria:

- severe chronic illness

- limited range of arm motion

- required use of prescription medication

- required use of dietary supplements
We found this trial at
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Kannapolis, North Carolina 28081
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Kannapolis, NC
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