Nutritional Prevention of Exertional Muscle Dysfunction (MUSREC)
Primary Purpose
Muscle Dysfunction, Exertional Rhabdomyolysis, Muscle Strength
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choline
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Muscle Dysfunction focused on measuring muscle, muscle dysfunction, choline, exercise, exertional rhabdomyolysis, rhabdomyolysis
Eligibility 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
Sites / Locations
- UNC Nutrition Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Choline
Placebo
Arm Description
Phosphatidyl choline
Vegetable oil
Outcomes
Primary Outcome Measures
Creatine Kinase (CK) activity
CK activity in response to an exertional challenge will be measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT01722448
First Posted
November 2, 2012
Last Updated
October 12, 2017
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01722448
Brief Title
Nutritional Prevention of Exertional Muscle Dysfunction
Acronym
MUSREC
Official Title
Nutritional Prevention of Exertional Muscle Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Dysfunction, Exertional Rhabdomyolysis, Muscle Strength
Keywords
muscle, muscle dysfunction, choline, exercise, exertional rhabdomyolysis, rhabdomyolysis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choline
Arm Type
Experimental
Arm Description
Phosphatidyl choline
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vegetable oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Choline
Intervention Description
4 capsules with 480 mg choline per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Creatine Kinase (CK) activity
Description
CK activity in response to an exertional challenge will be measured.
Time Frame
3 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kohlmeier, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Nutrition Research Institute
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nutritional Prevention of Exertional Muscle Dysfunction
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