Dietary Intake and Circulating Levels of Branched Chain Amino Acids

NCT ID: NCT02110602

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-08-31

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.

Conditions

Dietary Intake of Branched Chain Amino Acids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Diet high in amino acid levels

Intervention Type: OTHER

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.

Diet low in amino acid levels

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Diet high in amino acid levels

Intervention Type: OTHER

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.

Diet low in amino acid levels

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Amino Acid supplements to be used in prepared meals: Vitaflo MSUD express; l-isoleucine; l-leucine; l-valine

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geoffrey Walford, MD

Geoffrey Walford, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffrey Walford, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26781817 (View on PubMed)

Other Identifiers

2013P002607

Identifier Type: -

Identifier Source: org_study_id