Dietary Intake and Circulating Levels of Branched Chain Amino Acids

Short-term Dietary Intake and Branched Chain Amino Acids

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.

Study Overview

• Status: Completed
• Conditions: Dietary Intake of Branched Chain Amino Acids
• Intervention / Treatment: Other: Diet high in amino acid levels; Other: Diet low in amino acid levels

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Diet - high in amino acid levels; Visit 1 (Day 1): Screening Visit Visit 2 (14-21 days after Visit 1): Begin high amino acid diet Visit 3 (4 days after Visit 2): Completion of high amino acid diet Visit 4 (3 days after Visit 3): Begin low amino acid diet Visit 5 (4 days after Visit 4): Completion of low amino acid diet, completion of study	Other: Diet high in amino acid levels; Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.; Other Names: Amino Acid supplements to be used in prepared meals:; Vitaflo MSUD express; l-isoleucine; l-leucine; l-valine; Other: Diet low in amino acid levels; Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
Experimental: Initial Diet - low in amino acid levels; Visit 1 (Day 1): Screening Visit Visit 2 (14-21 days after Visit 1): Begin low amino acid diet Visit 3 (4 days after Visit 2): Completion of low amino acid diet Visit 4 (3 days after Visit 3): Begin high amino acid diet Visit 5 (4 days after Visit 4): Completion of high amino acid diet, completion of study	Other: Diet high in amino acid levels; Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.; Other Names: Amino Acid supplements to be used in prepared meals:; Vitaflo MSUD express; l-isoleucine; l-leucine; l-valine; Other: Diet low in amino acid levels; Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Branch Chain Amino Acid levels following diet interventions	A comparison of branched chain amino acid levels (as measured by mass spectrometry) following 4 days of a low and following 4 days of a high BCAA-content diet	4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting BCAA levels from native dietary intake to completion of diet intervention	4 days

Other Outcome Measures

Outcome Measure	Time Frame
Comparison of fasting glucose and insulin levels following diet interventions	4 days
Change in fasting glucose and insulin levels from native dietary intake to completion of diet intervention	4 days
Tolerance of diet interventions	4 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Geoffrey Walford, M.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Nutrition
• Other Study ID Numbers: 2013P002607