The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients

Conditions
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Type 2 Diabetes, Healthy Individuals

Intervention / Treatment
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* Dietary Supplement: Branched Chained Amino Acids
* Other: Cellulose Placebo mix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Branched Chained Amino Acids<br> | Dietary Supplement: Branched Chained Amino Acids<br>* 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<br>* Other names: Isoleucine, Leucine, and Valine;|
| Placebo Comparator: Cellulose mix<br> | Other: Cellulose Placebo mix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Pain, using the short form McGill pain questionnaire |  | 5 days following the initial exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Muscle strength of the studied muscle |  | 5 days following the initial exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Branched Chained Amino Acids, Delayed Onset Muscle Soreness, Diabetes, Muscle Damage