Nutritional Prevention of Exertional Muscle Dysfunction (MUSREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01722448
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : October 16, 2017
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
Muscle Dysfunction Exertional Rhabdomyolysis Muscle Strength Dietary Supplement: Choline Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Nutritional Prevention of Exertional Muscle Dysfunction
Study Start Date : November 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Choline
Phosphatidyl choline
Dietary Supplement: Choline
4 capsules with 480 mg choline per day
Placebo Comparator: Placebo
Vegetable oil
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Creatine Kinase (CK) activity [ Time Frame: 3 weeks ]
    CK activity in response to an exertional challenge will be measured.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01722448

United States, North Carolina
UNC Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Martin Kohlmeier, MD University of North Carolina

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01722448     History of Changes
Other Study ID Numbers: 12-0504
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by University of North Carolina, Chapel Hill:
muscle dysfunction
exertional rhabdomyolysis

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents