The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of muscle pain which usually develops after exercising.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Oct 2010
Shorter than P25 for not_applicable type-2-diabetes
1 active site
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
First Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 22, 2011
April 1, 2011
5 months
September 28, 2010
April 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measuring Pain, using the short form McGill pain questionnaire
5 days following the initial exercise
Secondary Outcomes (1)
Measuring Muscle strength of the studied muscle
5 days following the initial exercise
Study Arms (2)
Branched Chained Amino Acids
EXPERIMENTALCellulose mix
PLACEBO COMPARATORInterventions
Two doses of the Branched Chained Amino Acid supplement will be taken. The first dose will be taken 35 minutes before the intended exercise, and the other dose will be taken right after completing the exercise. The amount of the Branched Chained Amino Acid supplement administered to the subjects in the experimental group will vary from one person to the other but a total dose of 1 gram of BCAA per kilogram of lean body mass will be used. This dose will be divided in half and administered at the two specified occasions. The ratio of isoleucine, leucine, and valine will be 1:2.5:1 respectively
The control group will also take 2 doses, 1 before the exercise, and the other after completing the exercise. This dose will be divided in half and administered at the two specified occasions.
Eligibility Criteria
You may qualify if:
- The subjects with diabetes must have been diagnosed with diabetes at least one year before the onset of the study
- At least 6 weeks of physical inactivity in the upper body
- BMI less than 40
You may not qualify if:
- For the Diabetics, hemoglobin A1c levels over 13
- Pregnant
- Have Cardiovascular diseases
- Have Hepatic diseases
- Are diagnosed with Rhabdomyolysis
- Recent upper limb injuries
- Upper limb neuropathy
- Blood Pressure levels over 140/90, or lower than 90/60
- Are on High doses of alpha or beta agonist/antagonists, and take any types of NSAID's, Cox 2 inhibitors, Calcium channel blockers, Pre-Gabalin's, or Pain reducers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University, School of Allied Health Professions
Loma Linda, California, 92354, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold Petrofsky, Doctoral PhD
Loma Linda University, School of Allied Health Professions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 29, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
April 22, 2011
Record last verified: 2011-04