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Low branched-chain amino acids(BCAA) diet for Obesity (SOAR-2 Trial)

Phase < 1
Waitlist Available
Led By Dawn B Davis, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Awards & highlights

SOAR-2 Trial Summary

This trial will help determine whether low protein or low BCAA diets are more effective for weight loss and improving metabolic health in humans.

Eligible Conditions
  • Obesity
  • Diabetes

SOAR-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fasting blood glucose level
Change in weight
Secondary outcome measures
Change in Energy expenditure as measured by resting metabolic rate
Change in Fibroblast growth factor 21 (FGF21) levels
Change in Insulin sensitivity
+4 more

SOAR-2 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Low branched-chain amino acids (BCAA)Experimental Treatment1 Intervention
The group on low-BCAA diet will consume 2 meal replacement beverages (MRBs) per day made with BCAD2 (branched chain amino acid) powder (lacking BCAAs). BCAD2 powder(Mead Johnson) is a fortified medical food powder that does not contain the BCAAs isoleucine, leucine, or valine, but provides all other essential and nonessential AAs, carbohydrates, fat, vitamins, and minerals. No overall calorie reduction will be implemented for any group. All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content. The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.
Group II: Low protein(LP) dietActive Control1 Intervention
This group will consume 2 meal replacement beverages(MRBs) containing low protein (goal to reduce total protein by 2/3rds). LP diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment. No overall calorie reduction will be implemented for any group. All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content. The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.
Group III: ControlPlacebo Group1 Intervention
A control group will consume 2 meal replacement beverages(MRBs) made with whey protein The control diet group will be provided with a protein powder which will provide all Amino Acids. Diets will be provided in unmarked containers, to ensure subjects will be blinded to the dietary group assignment. No overall calorie reduction will be implemented for any group. All subjects will receive recipes developed by clinical nutritionist in the study team. Theses recipes will maximize palatability and match energy density across all diets and total protein content. The subjects will be able to use multiple different recipes over the course of the study to prevent taste fatigue and dropout. Each subject is anticipated to replace 2 meals per day with a beverage.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,544 Total Patients Enrolled
28 Trials studying Obesity
8,520 Patients Enrolled for Obesity
Dawn B Davis, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Obesity
16 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids
2024. "SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04424537.
~0 spots leftby Jan 2028
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