Clinical trial NCT02110602: Dietary Intake and Circulating Levels of Branched Chain Amino Acids
Official title: Short-term Dietary Intake and Branched Chain Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Intake of Branched Chain Amino Acids
Keywords: Nutrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 5
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Comparison of Branch Chain Amino Acid levels following diet interventions
timeFrame: 4 days
Secondary outcomes:
measure: Change in fasting BCAA levels from native dietary intake to completion of diet intervention
timeFrame: 4 days
Other outcomes:
measure: Comparison of fasting glucose and insulin levels following diet interventions
timeFrame: 4 days
measure: Change in fasting glucose and insulin levels from native dietary intake to completion of diet intervention
timeFrame: 4 days
measure: Tolerance of diet interventions
timeFrame: 4 days
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Geoffrey Walford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavallaro NL, Garry J, Shi X, Gerszten RE, Anderson EJ, Walford GA. A pilot, short-term dietary manipulation of branched chain amino acids has modest influence on fasting levels of branched chain amino acids. Food Nutr Res. 2016 Jan 14;60:28592. doi: 10.3402/fnr.v60.28592. eCollection 2016.