Nutritional Prevention of Exertional Muscle Dysfunction (MUSREC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Muscle Dysfunction Exertional Rhabdomyolysis Muscle Strength |
Dietary Supplement: Choline Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Nutritional Prevention of Exertional Muscle Dysfunction |
- Creatine Kinase (CK) activity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]CK activity in response to an exertional challenge will be measured.
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Choline
Phosphatidyl choline
|
Dietary Supplement: Choline
4 capsules with 480 mg choline per day
|
|
Placebo Comparator: Placebo
Vegetable oil
|
Dietary Supplement: Placebo |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Martin Kohlmeier, MD | (704) 250-5023 | mkohlmeier@unc.edu |
| United States, North Carolina | |
| UNC Nutrition Research Institute | Recruiting |
| Kannapolis, North Carolina, United States, 28081 | |
| Principal Investigator: Martin Kohlmeier, MD | |
| Principal Investigator: | Martin Kohlmeier, MD | University of North Carolina |
More Information
No publications provided
| Responsible Party: | Martin Kohlmeier, MD, Research Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01722448 History of Changes |
| Other Study ID Numbers: | 12-0504 |
| Study First Received: | November 2, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
muscle muscle dysfunction choline |
exercise exertional rhabdomyolysis rhabdomyolysis |
Additional relevant MeSH terms:
|
Rhabdomyolysis Muscular Diseases Musculoskeletal Diseases Choline Lipotropic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013