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

Obesity Clinical Trial

— SOAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239717
• Other study ID #: 2017-0099
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: July 16, 2021

Study information

• Verified date: March 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male between the age of 35 - 65

2. BMI between 28 - 35 (mildly obese/overweight)

3. Fasting glucose level of 101 - 125 mg/dL

4. Able and willing to give written informed consent

5. Stable weight (within 5 lbs. for at least 3 months)

6. Not taking (or willing to cease taking) over the counter vitamin/mineral supplements

7. Not planning to begin an exercise or diet program

Exclusion Criteria:

1. Female

2. Outside required age range of 35 - 65

3. BMI not within range of 28 - 35

4. Fasting glucose not within range of 101 - 125 mg/dL

5. Use of prescription medications for diabetes or weight-loss

6. 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).

7. Low baseline albumin or pre-albumin levels (below normal reference range)

8. Significant anemia (Hemoglobin < 11 g/dL)

9. Known bleeding disorder or platelet dysfunction

10. Already eating a low protein diet (less than 14% total caloric intake from protein), as calculated from food diaries provided by subjects

11. 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.

12. Significant co-morbidities (including kidney disease, liver disease, GI disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder).

13. Planned smoking cessation or attempt at smoking cessation during study period

14. Inability to tolerate meal replacement beverages due to palatability

15. Recent weight loss (> 5 lbs within 3 months).

16. Bariatric surgery, gastric banding or liposuction

17. Current or past (within 1 year) use of illicit drugs

18. Claustrophobia

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Obesity

Intervention

Other:
• Whey protein powder
Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.
• BCAD2
Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Weight	Weight in kg	3 months
Secondary	Fat mass	Fat mass in kg	3 months
Secondary	BMI	Weight in kg and height in meters will be combined to report BMI in kg/m^2	3 months
Secondary	Resting metabolic rate	Resting metabolic rate in kcal/hour	3 months
Secondary	Fasting blood glucose	Fasting blood glucose in mg/dL	3 months
Secondary	Insulin	Insulin in ng/dL	3 months
Secondary	HbA1c	HbA1c in mmol/mol	3 months
Secondary	Glucose tolerance	Area under the curve in mg/dL/min	3 months