NCT01722448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

November 2, 2012

Last Update Submit

October 12, 2017

Conditions

Muscle DysfunctionExertional RhabdomyolysisMuscle Strength

Keywords

musclemuscle dysfunctioncholineexerciseexertional rhabdomyolysisrhabdomyolysis

Outcome Measures

Primary Outcomes (1)

  • Creatine Kinase (CK) activity

    CK activity in response to an exertional challenge will be measured.

    3 weeks

Study Arms (2)

Choline

EXPERIMENTAL

Phosphatidyl choline

Dietary Supplement: Choline

Placebo

PLACEBO COMPARATOR

Vegetable oil

Dietary Supplement: Placebo

Interventions

CholineDIETARY_SUPPLEMENT

4 capsules with 480 mg choline per day

Choline
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian
  • choline intake less than 450 mg
  • exertional muscle dysfunction
  • susceptible genetic profile

You may not qualify if:

  • severe chronic illness
  • limited range of arm motion
  • required use of prescription medication
  • required use of dietary supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor ActivityRhabdomyolysis

Interventions

Choline

Condition Hierarchy (Ancestors)

BehaviorMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Officials

  • Martin Kohlmeier, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 6, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

US(1)