Status:
WITHDRAWN
SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
30-65 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Use of prescription medications for diabetes or weight-loss
- Diabetes - fasting glucose level of greater than 125 mg/dL and/or hemoglobin A1C( HbA1c or A1C) above 6.4%
- Use of and unwillingness to discontinue 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
- 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
- Bariatric surgery, gastric banding or liposuction
- Current or past (within 1 year) use of illicit drugs
- 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
- Allergy to racemethionine
- Lactose intolerance
- Pregnancy or plans to conceive within 4 months of visit 1
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04424537
Start Date
January 1 2024
End Date
January 1 2028
Last Update
August 4 2022
Active Locations (1)
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1
University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, United States, 53726