Nutritional Prevention of Exertional Muscle Dysfunction (MUSREC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Martin Kohlmeier, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01722448
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722448

Contacts
Contact: Martin Kohlmeier, MD (704) 250-5023 mkohlmeier@unc.edu

Locations
United States, North Carolina
UNC Nutrition Research Institute Recruiting
Kannapolis, North Carolina, United States, 28081
Principal Investigator: Martin Kohlmeier, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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 September 18, 2014