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DiabetesSOARNCT03239717

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

A study testing Whey protein powder and BCAD2 in people with Diabetes and Obesity, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes, Obesity, Insulin Resistance
What is being tested?
Whey protein powder and BCAD2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
28 Nov 2017to 16 Jul 2021
Phase
Interventional
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 35 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 18Show fewer
  • 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).
  • Bariatric surgery, gastric banding or liposuction
  • Current or past (within 1 year) use of illicit drugs
  • Claustrophobia

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

Other trials in United States

About this study

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.

Read the detailed description

This study, which will be completed over three months, involves replacing two meals a day with meal replacement beverages for two months, with a one month follow-up visit. These beverages will be made up by subjects using either a complete protein powder or BCAD2, a BCAA-free medical food. Participants will complete food diaries at baseline and at one month intervals during the study, and compliance will be assessed via food diaries, weekly telephone contact, and measuring returned food powder.

Being tested
Whey protein powder, BCAD2
Medical subject headings
Diabetes Mellitus, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey protein powderOther

    Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.

  • BCAD2Other

    Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.

Study groups in NCT03239717
Study groupRoleWhat they receive
Whey protein powderPlacebo comparatorParticipants in the Placebo Arm will replace two-thirds of participants dietary protein intake with meal replacement beverages utilizing a complete protein powder.
Receives: Other: Whey protein powder
ExperimentalExperimentalParticipants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
Receives: Other: BCAD2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (8)

  1. Weight

    Weight in kg

    Measured: 3 months

  2. Fat mass

    Fat mass in kg

    Measured: 3 months

  3. BMI

    Weight in kg and height in meters will be combined to report BMI in kg/m^2

    Measured: 3 months

  4. Resting metabolic rate

    Resting metabolic rate in kcal/hour

    Measured: 3 months

  5. Fasting blood glucose

    Fasting blood glucose in mg/dL

    Measured: 3 months

  6. Insulin

    Insulin in ng/dL

    Measured: 3 months

  7. HbA1c

    HbA1c in mmol/mol

    Measured: 3 months

  8. Glucose tolerance

    Area under the curve in mg/dL/min

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2017
  2. Study start28 Nov 2017
  3. Primary completion16 Jul 2021
  4. Study completion16 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03239717
Sponsor's protocol ID
2017-0099
Other IDs
Protocol Version 2/23/2021, A534245, SMPH\MEDICINE\ENDOCRINOL
Acronym
SOAR
Status last verified
Mar 2021
First submitted
16 May 2017
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27346343

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein powder and BCAD2 in people with Diabetes and Obesity, 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 30 Jul 2021. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Reduction of BCAA intake (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03239717, which also lists 1 linked publication.

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 30 Jul 2021.

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