ObesityEarly Phase 1SOAR-2NCT04424537
SOAR-2: Intervening in Obesity Through Reduction of Dietary Branched Chain Amino Acids
A Early Phase 1 study testing Low branched-chain amino acids(BCAA) diet and Low protein diet in people with Obesity and Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 notoriously difficult to sustain. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Low branched-chain amino acids(BCAA) diet and Low protein diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Jan 2028
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, 53726
About this study
Official title: The Metabolic Response to Reduced Branched-chain Amino Acids in Humans 2
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.
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.
- Being tested
- Control diet, Low branched-chain amino acids(BCAA) diet, Low protein diet
- Keywords
- Calorie restriction
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietDietary supplement
Meal replacement beverages made with whey protein
Low branched-chain amino acids(BCAA) dietDietary supplement
meal replacement beverages (MRBs) made with BCAD2 powder (lacking BCAAs).
Low protein dietDietary supplement
meal replacement beverages(MRBs) containing low protein
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Dietary Supplement: Control diet |
| Low protein(LP) diet | Active comparator | 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. Receives: Dietary Supplement: Low protein diet |
| Low branched-chain amino acids (BCAA) | Experimental | 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. Receives: Dietary Supplement: Low branched-chain amino acids(BCAA) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Change in participant weight
Measured: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Change in fasting blood glucose level
Change in the participant's fasting blood glucose level
Measured: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Secondary outcomes (7)
Change in the body composition (adipose mass) as measured by DXA/BIS
Dual energy X-ray absorptiometry (DXA) is a standard technique for the determination of body composition. DXA results will be used to calculate fat and lean mass composition. Total body Bioelectrical Impedance Spectroscopy (BIS) is a minimal risk procedure which enhances DXA as it permits the determination of intracellular water.BIS is used to calculate fat and fat-free mass composition. A formula will be used to combine BIS fat-free mass composition and DXA lean mass composition corrected by limb length, which allows a surrogate measurement of muscle mass.
Measured: Baseline, 60(-3 to +7)days
Change in Insulin sensitivity
Insulin resistance will be measured by HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) method. Insulin resistance reveals the dynamics between the participant's baseline (fasting) blood sugar and the responsive insulin levels.
HOMA-IR healthy range: 1.0 (0.5-1.4), less than 1.0 means participant is insulin-sensitive which is optimal, above 1.9 indicates early insulin resistance, above 2.9 indicates significant insulin resistance.
Measured: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Change in Fibroblast growth factor 21 (FGF21) levels
Fibroblast growth factor 21 (FGF21) is a hormone which regulate insulin signalling in response to nutritional status. Levels of FGF21 induced in response to low protein diet and fasting will be measured using enzyme-linked immunosorbent assay(ELISA) assay.
Measured: Baseline, 30 (±7)days, 60(-3 to +7)days
Change in Energy expenditure as measured by resting metabolic rate
Energy expenditure will be calculated from resting metabolic rate. Resting metabolic rate is the energy required by the body to perform the most basic functions when body is at rest.
Measured: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by jump maximal height
Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform. Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Maximal jump height(meter) will be calculated using Leonardo software.
Measured: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by jump velocity
Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal counter-movement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Jump velocity [meter/sec] will be calculated using Leonardo software.
Measured: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by relative power of jump
Jumping mechanography will be used to quantify muscle function. Jumping mechanography involves 3 supervised jumps on a force measurement platform.Analysis will be conducted on variables associated with the highest achieved jump height of the 3 trials.
In Jumping mechanography, participants perform two-leg maximal countermovement jumps on a force plate (Leonardo, Novotec, Pforzheim, Germany). Relative power of jump [Watt/kg] will be calculated using Leonardo software.
Measured: Baseline, 60(-3 to +7)days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startJan 2024 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: Withdrawn due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn B Davis, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424537
- Sponsor's protocol ID
- 2019-0701
- Other IDs
- A534245, SMPH/MEDICINE/ENDOCRINOL, Protocol Version 3/1/2021
- Acronym
- SOAR-2
- Status last verified
- Aug 2022
- First submitted
- 2 Jun 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Response to Reduced Branched-chain Amino Acids in Humans 2
- ClinicalTrials.gov ID
- NCT04424537
- Acronym / sponsor ID
- SOAR-2 / 2019-0701
- Keywords
- Calorie restriction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control dietA 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. |
| Low protein(LP) diet | Active comparator | Dietary Supplement: Low protein dietThis 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. |
| Low branched-chain amino acids (BCAA) | Experimental | Dietary Supplement: Low branched-chain amino acids(BCAA) dietThe 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control dietMeal replacement beverages made with whey protein | Dietary supplement | Control |
| Low branched-chain amino acids(BCAA) dietmeal replacement beverages (MRBs) made with BCAD2 powder (lacking BCAAs). | Dietary supplement | Low branched-chain amino acids (BCAA) |
| Low protein dietmeal replacement beverages(MRBs) containing low protein | Dietary supplement | Low protein(LP) diet |
Primary outcome
Change in weight
Time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Change in participant weight
Change in fasting blood glucose level
Time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Change in the participant's fasting blood glucose level
7 secondary outcomes
Change in the body composition (adipose mass) as measured by DXA/BIS
Time frame: Baseline, 60(-3 to +7)days
Change in Insulin sensitivity
Time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days
Change in Fibroblast growth factor 21 (FGF21) levels
Time frame: Baseline, 30 (±7)days, 60(-3 to +7)days
Change in Energy expenditure as measured by resting metabolic rate
Time frame: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by jump maximal height
Time frame: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by jump velocity
Time frame: Baseline, 60(-3 to +7)days
Change in Muscle function as measured by relative power of jump
Time frame: Baseline, 60(-3 to +7)days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn B Davis, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low branched-chain amino acids(BCAA) diet and Low protein diet in people with Obesity and Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline, 30 (±7)days, 60(-3 to +7)days, 134(+7) days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.