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Completed

NCT Number: NCT02110602

Dietary Intake and Circulating Levels of 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.

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Key information

Conditions

Dietary Intake of Branched Chain Amino Acids

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet high in amino acid levels

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.

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

Diet low in amino acid levels

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.

Primary outcomes

  1. Comparison of Branch Chain Amino Acid levels following diet interventions

    Time frame: 4 days

    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

Secondary outcomes

  1. Change in fasting BCAA levels from native dietary intake to completion of diet intervention

    Time frame: 4 days

Other outcomes

  1. Comparison of fasting glucose and insulin levels following diet interventions

    Time frame: 4 days

  2. Change in fasting glucose and insulin levels from native dietary intake to completion of diet intervention

    Time frame: 4 days

  3. Tolerance of diet interventions

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Short-term Dietary Intake and Branched Chain Amino Acids

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2014
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.