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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211717
• Other study ID #: 5100233
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: April 21, 2011
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy Individuals
• Myalgia
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University, School of Allied Health Professions	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Pain, using the short form McGill pain questionnaire		5 days following the initial exercise	No
Secondary	Measuring Muscle strength of the studied muscle		5 days following the initial exercise	No