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

NCT ID: NCT01211717

Last Updated: 2011-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-04-30

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.

Conditions

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Type 2 Diabetes Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Branched Chained Amino Acids

Group Type EXPERIMENTAL

Branched Chained Amino Acids

Intervention Type DIETARY_SUPPLEMENT

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

Cellulose mix

Group Type PLACEBO_COMPARATOR

Cellulose Placebo mix

Intervention Type OTHER

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.

Interventions

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Branched Chained Amino Acids

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 DIETARY_SUPPLEMENT

Cellulose Placebo mix

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.

Intervention Type OTHER

Other Intervention Names

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Isoleucine, Leucine, and Valine

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Loma Linda University, School of Allied Health Professions

Principal Investigators

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Jerrold Petrofsky, Doctoral PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University, School of Allied Health Professions

Locations

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Loma Linda University, School of Allied Health Professions

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5100233

Identifier Type: -

Identifier Source: org_study_id

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