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

NCT03239717 | Completed

• 4 other identifiers: 2017-0099Protocol Version 2/23/2021A534245SMPH\MEDICINE\ENDOCRINOL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Weight

  3 months

• Fat mass

  3 months

• BMI

  3 months

• Resting metabolic rate

  3 months

• Fasting blood glucose

  3 months

Study Arms (2)

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.

Other: Whey protein powder

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.

Other: BCAD2

Interventions

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.

Whey protein powder

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.

Experimental

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53726, United States

Location

Related 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.

  PMID: 27346343 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Dudley W Lamming, PhD

  UW-Madison

  PRINCIPAL INVESTIGATOR

• Dawn B Davis, MD, PhD

  UW-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: August 4, 2017
• Study Start: November 28, 2017
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)