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

Primary Purpose

Diabetes, Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey protein powder
BCAD2
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin-Madison School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Whey protein powder

Experimental

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight
Weight in kg
Fat mass
Fat mass in kg
BMI
Weight in kg and height in meters will be combined to report BMI in kg/m^2
Resting metabolic rate
Resting metabolic rate in kcal/hour
Fasting blood glucose
Fasting blood glucose in mg/dL
Insulin
Insulin in ng/dL
HbA1c
HbA1c in mmol/mol
Glucose tolerance
Area under the curve in mg/dL/min

Full Information

First Posted
May 16, 2017
Last Updated
July 28, 2021
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03239717
Brief Title
The Metabolic Response to Reduced Branched-chain Amino Acids in Humans
Acronym
SOAR
Official Title
The Metabolic Response to Reduced Branched-chain Amino Acids in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey protein powder
Arm Type
Placebo Comparator
Arm Description
Participants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Whey protein powder
Intervention Description
Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.
Intervention Type
Other
Intervention Name(s)
BCAD2
Intervention Description
Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
Primary Outcome Measure Information:
Title
Reduction of BCAA intake
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight
Description
Weight in kg
Time Frame
3 months
Title
Fat mass
Description
Fat mass in kg
Time Frame
3 months
Title
BMI
Description
Weight in kg and height in meters will be combined to report BMI in kg/m^2
Time Frame
3 months
Title
Resting metabolic rate
Description
Resting metabolic rate in kcal/hour
Time Frame
3 months
Title
Fasting blood glucose
Description
Fasting blood glucose in mg/dL
Time Frame
3 months
Title
Insulin
Description
Insulin in ng/dL
Time Frame
3 months
Title
HbA1c
Description
HbA1c in mmol/mol
Time Frame
3 months
Title
Glucose tolerance
Description
Area under the curve in mg/dL/min
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dudley W Lamming, PhD
Organizational Affiliation
UW-Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn B Davis, MD, PhD
Organizational Affiliation
UW-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53726
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27346343
Citation
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.
Results Reference
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The Metabolic Response to Reduced Branched-chain Amino Acids in Humans

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