The Metabolic Response to Reduced Branched-chain Amino Acids in Humans

Completed · Not applicable

Conditions studied: Diabetes, Obesity, Insulin Resistance

In brief

Branched-chain amino acids (BCAAs) are essential nutrients that the body obtains from proteins found in food, especially meat, diary products, and legumes. Data from rodent studies suggest that reduction of dietary BCAAs will promote fat mass loss and improved control of blood glucose. The purpose of this study is to test if reduction of dietary BCAAs without reducing calorie intake will lead to similar metabolic benefits in humans. Here the investigators test the feasibility of reducing dietary BCAAs using BCAA-free meal replacement beverages for two months.

Key facts

Study ID

NCT03239717

Run by

University of Wisconsin, Madison

People needed

16

Starts

2017-11-28

Expected to finish

2021-07-16

Last updated by the study team

2021-07-30

Who can join

Age: 35 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male between the age of 35 - 65
• BMI between 28 - 35 (mildly obese/overweight)
• Fasting glucose level of 101 - 125 mg/dL
• Able and willing to give written informed consent
• Stable weight (within 5 lbs. for at least 3 months)
• Not taking (or willing to cease taking) over the counter vitamin/mineral supplements
• Not planning to begin an exercise or diet program

You may not qualify if…

• Female
• Outside required age range of 35 - 65
• BMI not within range of 28 - 35
• Fasting glucose not within range of 101 - 125 mg/dL
• Use of prescription medications for diabetes or weight-loss
• Use of and unwillingness to discontinue over the counter supplements (e.g. cinnamon, chromium, protein powders) or weight loss beverage or meal plans (e.g. SlimFast or Jenny Craig).
• Low baseline albumin or pre-albumin levels (below normal reference range)
• Significant anemia (Hemoglobin < 11 g/dL)
• Known bleeding disorder or platelet dysfunction
• Already eating a low protein diet (less than 14% total caloric intake from protein), as calculated from food diaries provided by subjects
• Participating in intensive exercise training program (high to moderate intensity exercise greater than 210 minutes per week) or planning to start new exercise program during study period.
• Significant co-morbidities (including kidney disease, liver disease, GI disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder).
• Planned smoking cessation or attempt at smoking cessation during study period
• Inability to tolerate meal replacement beverages due to palatability
• Recent weight loss (> 5 lbs within 3 months).
• Bariatric surgery, gastric banding or liposuction
• Current or past (within 1 year) use of illicit drugs
• Claustrophobia

Where it is running

• University of Wisconsin-Madison School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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