The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Primary Purpose
Type 2 Diabetes, Healthy Individuals
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Branched Chained Amino Acids
Cellulose Placebo mix
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Branched Chained Amino Acids, Delayed Onset Muscle Soreness, Diabetes, Muscle Damage
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Loma Linda University, School of Allied Health Professions
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Branched Chained Amino Acids
Cellulose mix
Arm Description
Outcomes
Primary Outcome Measures
Measuring Pain, using the short form McGill pain questionnaire
Secondary Outcome Measures
Measuring Muscle strength of the studied muscle
Full Information
NCT ID
NCT01211717
First Posted
September 28, 2010
Last Updated
April 21, 2011
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT01211717
Brief Title
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Official Title
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Delayed Onset Muscle Soreness is a common painful sensation experienced by individuals who have been recently inactive and begin with an unaccustomed exercise protocol. Branched Chained Amino Acids have been found as a useful supplement for promoting muscle recovery following exercise; however the effects of this supplement have not been investigated amongst individuals with diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Healthy Individuals
Keywords
Branched Chained Amino Acids, Delayed Onset Muscle Soreness, Diabetes, Muscle Damage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Branched Chained Amino Acids
Arm Type
Experimental
Arm Title
Cellulose mix
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Branched Chained Amino Acids
Other Intervention Name(s)
Isoleucine, Leucine, and Valine
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cellulose Placebo mix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring Pain, using the short form McGill pain questionnaire
Time Frame
5 days following the initial exercise
Secondary Outcome Measure Information:
Title
Measuring Muscle strength of the studied muscle
Time Frame
5 days following the initial exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Petrofsky, Doctoral PhD
Organizational Affiliation
Loma Linda University, School of Allied Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University, School of Allied Health Professions
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
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