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

NCT ID: NCT03239717

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-28
• Study Completion Date: 2021-07-16

Brief 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.

Detailed 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.

Conditions

Diabetes; Obesity; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Whey protein powder

Participants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder.

Group Type: PLACEBO_COMPARATOR

Whey protein powder

Intervention Type: OTHER

Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.

Experimental

Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.

Group Type: EXPERIMENTAL

BCAD2

Intervention Type: OTHER

Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.

Interventions

Whey protein powder

Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.

Intervention Type: OTHER

BCAD2

Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dudley W Lamming, PhD

Role: PRINCIPAL_INVESTIGATOR

UW-Madison

Dawn B Davis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UW-Madison

Locations

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27346343 (View on PubMed)

Other Identifiers

Protocol Version 2/23/2021

Identifier Type: OTHER

Identifier Source: secondary_id

A534245

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\ENDOCRINOL

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0099

Identifier Type: -

Identifier Source: org_study_id