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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 2/23/2021 | Other Identifier | UW Madison | |
| A534245 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\ENDOCRINOL | Other Identifier | UW Madison |
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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.
This study, which will be completed over three months, involves replacing two meals a day with meal replacement beverages for two months, with a one month follow-up visit. These beverages will be made up by subjects using either a complete protein powder or BCAD2, a BCAA-free medical food. Participants will complete food diaries at baseline and at one month intervals during the study, and compliance will be assessed via food diaries, weekly telephone contact, and measuring returned food powder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein powder | Placebo Comparator | Participants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder. |
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| Experimental | Experimental | Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein powder | Other | Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of BCAA intake | The principle outcome of this study is to determine if replacing 2/3rds of the subjects baseline protein intake with BCAA-free meal replacement beverages are a feasible method of selectively reducing BCAA consumption. Our principle outcome is to reduce BCAA intake by 50% or more in the Experimental Arm (BCAD2) of the study as compared to baseline intake. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight in kg | 3 months |
| Fat mass | Fat mass in kg | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dudley W Lamming, PhD | UW-Madison | Principal Investigator |
| Dawn B Davis, MD, PhD | UW-Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison School of Medicine and Public Health | Madison | Wisconsin | 53726 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27346343 | Background | Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| BCAD2 | Other | Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food. |
|
| BMI |
Weight in kg and height in meters will be combined to report BMI in kg/m^2 |
| 3 months |
| Resting metabolic rate | Resting metabolic rate in kcal/hour | 3 months |
| Fasting blood glucose | Fasting blood glucose in mg/dL | 3 months |
| Insulin | Insulin in ng/dL | 3 months |
| HbA1c | HbA1c in mmol/mol | 3 months |
| Glucose tolerance | Area under the curve in mg/dL/min | 3 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |