Dietary Intake and Circulating Levels of Branched Chain Amino Acids
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dietary Intake of Branched Chain Amino Acids
Intervention: Diet high in amino acid levels (Other); Diet low in amino acid levels (Other)
Phase: N/A
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Geoffrey Walford, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
The investigators are conducting this research study to find out if eating low or high
levels of specific amino acids changes the levels of these same amino acids in the blood.
Amino acids are the building blocks of protein that are normally found in food. The amino
acids the investigators are studying are called branched chain amino acids. The
investigators will look at the levels (amount) of branched chain amino acids in blood before
and after consumption of specially prepared meals. The investigators hypothesize that
circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content
diet compared with a high BCAA-content diet.
Clinical Details
Official title: Short-term Dietary Intake and Branched Chain Amino Acids
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Comparison of Branch Chain Amino Acid levels following diet interventions
Secondary outcome: Change in fasting BCAA levels from native dietary intake to completion of diet intervention
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Adult males
- Ages 20-40
- Healthy
Exclusion Criteria:
- Age less than 20 or greater than 40
- Female sex
- Use of medications and herbal or vitamin supplements during the study or less than
one month prior to enrollment in the study
- Body mass index (BMI) less than 20 or greater than 25
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior
to enrollment in the study
- Participation in more than 300 minutes of exercise per week during the month prior to
enrollment in the study or plans for changes in exercise level during the study
- Known diabetes or pre-diabetes (based on prior diagnoses; use of medications to lower
glucose; or fasting blood glucose > 100mg/dL at screening)
- Untreated hypertension (defined as systolic blood pressure > 140mmHg and diastolic
blood pressure > 90mmHg)
- Use of nicotine-containing products, including those inhaled, chewed, or patches
during the study.
- Use of drugs of abuse.
- Conditions causing intestinal malabsorption, including celiac disease or a history of
intestinal or gastric surgery
- Restrictions that prevent adherence to standardized meals or unwillingness to adhere
to a pre-specified meal plan, including abstinence from alcohol and limitation to 1
caffeinated beverage per day
- Known anemia (men, hematocrit < 38%) based on prior testing
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: April 2014
Last updated: August 3, 2014
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