SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids
Key facts
- Who runs it
- University of Wisconsin, Madison
- Where
- Madison, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Early phase 1
- Started
- Jan 2024
- Expected to end
- Jan 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Control diet
- Low branched-chain amino acids(BCAA) diet
- Low protein diet
- Record updated
- 4 August 2022
- Why it stopped
- Withdrawn due to lack of funding
Who can take part
- Age
- 30 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- BMI between 28 - 40 (overweight to obese)
- Baseline protein intake within normal adult ranges (15.1%-20.8% of calories from protein)
- 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) vitamin/mineral supplements, unless prescribed for a specific medical disorder
- Not planning to begin a new exercise or diet program
Who cannot take part
- Bariatric surgery, gastric banding or liposuction
- Current or past (within 1 year) use of illicit drugs
- Use of prescription medications for diabetes or weight-loss
- Significant co-morbidities (including kidney disease, liver disease, GI disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder)
- Allergy to racemethionine
- Diabetes - fasting glucose level of greater than 125 mg/dL and/or hemoglobin A1C( HbA1c or A1C) above 6.4%
- Low baseline albumin or pre-albumin levels (below normal reference range)
- Significant anemia (Hemoglobin < 11 g/dL)
- Known bleeding disorder or platelet dysfunction
- Use of and unwillingness to cease taking vitamin/mineral supplements and other over the counter supplements (e.g.,cinnamon, protein powders) that are known to affect weight and/or glucose tolerance, unless prescribed for a specific medical disorder
- Use of and unwillingness to discontinue weight loss beverage or meal plans (e.g. SlimFast or Jenny Craig)
- 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
- Planned smoking cessation or attempt at smoking cessation during study period
- Inability to tolerate meal replacement beverages due to palatability
- Lactose intolerance
- Pregnancy or plans to conceive within 4 months of visit 1
Where in United States
- University of Wisconsin-Madison School of Medicine and Public HealthMadison, United States
About the trial
What the trial wants to find out
One of the primary risk factors for the development of diabetes is obesity. While even moderate weight loss achieved by dieting can lead to improvements in metabolic health, reduced-calorie diets are notoriously difficult to sustain. Over the past decade, a number of groups have shown that low protein diets are associated with metabolic health in both rodents and humans. In particular, specific building blocks of protein- the branched chain amino acids (BCAAs) leucine, isoleucine, and valine - are associated with insulin resistance and diabetes in humans. Blood levels of the BCAAs decrease in humans fed a low protein diet, and we recently showed that reducing either dietary BCAAs or protein rapidly restored normal body composition and insulin sensitivity to diet-induced obese mice without reducing calorie intake.
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Current study will test the metabolic role of dietary BCAAs in humans by completing an adequately powered, randomized controlled study. A total of 132 subjects stratified by gender will be randomized to one of three groups: 1) Control; 2) Low Protein; 3) Low BCAA. Subjects in each group will replace two meals a day (and 2/3rds of their baseline dietary protein) with meal replacement beverages based on either complete protein powder or a BCAA-free medical food for two months. Primary outcomes will be weight and fasting blood glucose levels. A number of secondary outcomes will also be assessed and blood, adipose, and fecal samples will be collected for integrated transcriptional and metabolomic pathway analysis to identify and compare the metabolic pathways affected by low protein and low BCAA diets.
The 3 groups in the trial
- ControlPlacebo, for comparison
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.
Treatment: Control diet
- Low protein(LP) dietExisting treatment, for comparison
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.
Treatment: Low protein diet
- Low branched-chain amino acids (BCAA)Treatment being tested
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.
Treatment: Low branched-chain amino acids(BCAA) diet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Metabolic Response to Reduced Branched-chain Amino Acids in Humans 2
- Record updated
- 4 August 2022