Type 2 DiabetesNCT01211717
The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
A study testing Branched Chained Amino Acids in people with Type 2 Diabetes and Healthy Individuals, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Healthy Individuals
- What is being tested?
- Branched Chained Amino Acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- For the Diabetics, hemoglobin A1c levels over 13
- Pregnant
- Have Cardiovascular diseases
- Have Hepatic diseases
- Are diagnosed with Rhabdomyolysis
- Recent upper limb injuries
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University, School of Allied Health Professions
Loma Linda, California, 92354
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Healthy Individuals
- Being tested
- Branched Chained Amino Acids, Cellulose Placebo mix
- Keywords
- Branched Chained Amino Acids, Delayed Onset Muscle Soreness, Diabetes, Muscle Damage
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched Chained Amino AcidsDietary supplement
Also called Isoleucine, Leucine, and Valine
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 Placebo mixOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Branched Chained Amino Acids | Experimental | Not described Receives: Dietary Supplement: Branched Chained Amino Acids |
| Cellulose mix | Placebo comparator | Not described Receives: Other: Cellulose Placebo mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Pain, using the short form McGill pain questionnaire
Measured: 5 days following the initial exercise
Secondary outcomes (1)
Measuring Muscle strength of the studied muscle
Measured: 5 days following the initial exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Investigators
- Jerrold Petrofsky, Doctoral PhD, Principal investigator, Loma Linda University, School of Allied Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211717
- Sponsor's protocol ID
- 5100233
- Status last verified
- Apr 2011
- First submitted
- 28 Sep 2010
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01211717
- Acronym / sponsor ID
- 5100233
- Conditions
- Type 2 Diabetes, Healthy Individuals
- Keywords
- Branched Chained Amino Acids, Delayed Onset Muscle Soreness, Diabetes, Muscle Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branched Chained Amino Acids | Experimental | Dietary Supplement: Branched Chained Amino Acids |
| Cellulose mix | Placebo comparator | Other: Cellulose Placebo mix |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- For the Diabetics, hemoglobin A1c levels over 13
- Pregnant
- Have Cardiovascular diseases
- Have Hepatic diseases
- Are diagnosed with Rhabdomyolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched Chained Amino AcidsAlso: Isoleucine, Leucine, and ValineTwo 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 | Dietary supplement | Branched Chained Amino Acids |
| Cellulose Placebo mixThe 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. | Other | Cellulose mix |
Primary outcome
Measuring Pain, using the short form McGill pain questionnaire
Time frame: 5 days following the initial exercise
1 secondary outcome
Measuring Muscle strength of the studied muscle
Time frame: 5 days following the initial exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrold Petrofsky, Doctoral PhD principal investigator
Loma Linda University, School of Allied Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched Chained Amino Acids in people with Type 2 Diabetes and Healthy Individuals, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Pain, using the short form McGill pain questionnaire (time frame: 5 days following the initial exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2011.