Pre-diabetesNCT03715010
Investigation of an Amino Acid Supplement on Glucose Levels in Obese Subjects
A study testing BCAA in people with Pre-diabetes and Obese, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study aims to determine whether the use of Branched-Chain Amino Acids (BCAA's) regulate insulin and glucagon secretion, and whether the supplement has any effect on body weight and body composition. Subjects who participate in this study will receive an 8-week supply of supplement. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Obese, Glucose Intolerance
- What is being tested?
- BCAA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2016to 19 Jan 2018
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-65 years of age at screen
- BMI between 27 to 40
- Fasting glucose level >100, but <126 mg/dL or HgbA1c >5.7% but < 6.4%
- Waist circumference > 40 in for men and >35 in for women
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Who cannot join
- Any subject with a history of diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, cancer (except skin basal cell carcinoma ) chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Any subject who currently uses tobacco products.
- Any history of gastrointestinal disease except for appendectomy.
- Any antibiotic or laxative use during the 2 months before the study.
- Any subject who is unable or unwilling to comply with the study protocol.
- Any subject allergic to soy products.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutriiton
Los Angeles, California, 90095
About this study
Official title: Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-diabetic Subjects
This study aims to determine whether the use of Branched-Chain Amino Acids (BCAA's) regulate insulin and glucagon secretion, and whether the supplement has any effect on body weight and body composition. Subjects who participate in this study will receive an 8-week supply of supplement. The study supplements will be manufactured by Scientific Living, in Irvine, CA for high dose BCAA and the low dose BCAA is manufactured by Nutribiotic, Lakeport, CA. Timed blood collections will be used to measure how BCAA affect glucose metabolism/insulin sensitivity in human subjects.
Read the detailed description
- BCAA's multiple functions in cells In addition to participating in de novo protein synthesis, Branched-Chain Amino Acids (BCAAs, including leucine, isoleucine, and valine) regulate multiple cellular functions as nutrient signaling. For example, BCAAs regulate insulin and glucagon secretion and thus glucose metabolism1. BCAAs, especially leucine, is one key regulator of mTOR signaling, which is the central component of a complex signaling network of insulin signaling, cell growth, and proliferation. BCAAs also regulate protein synthesis and degradation in various tissues.
- Impact of BCAA supplemental or BCAA-enriched diet on metabolism In addition to the healthcare utilization of BCAAs for liver disorders and their complications and other diseases, BCAA supplementation is common amongst athletes and fitness professionals to improve muscle building and strength. Meanwhile, BCAA supplementation or BCAA-rich protein diets are often associated with positive effects on body weight and glucose homeostasis1. Increasing dietary uptake of BCAAs improved the parameters associated with obesity and T2DM, such as body composition and glycemia levels. However, these beneficial effects are not conclusive. Moreover, other studies have shown that circulating branched-chain amino acid concentrations are associated with obesity and future insulin resistance in children and adolescents2.
- Summary Both beneficial and detrimental effects of BCAA on metabolism have been established and therefore warrants further investigation. In the preliminary study, we found that BCAAs enhanced glucose metabolism in lean mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue.
- Conditions
- Pre-diabetes, Obese, Glucose Intolerance
- Being tested
- BCAA
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary supplement
Also called Branch Chain Amino Acid
Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa
| Study group | Role | What they receive |
|---|---|---|
| Brain Chain Amino Acid (BCAA) | Active comparator | Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design Receives: Dietary Supplement: BCAA |
| Placebo | Placebo comparator | Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design Receives: Dietary Supplement: BCAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of glucose AUC during 2H OGTT (Frame: 10 weeks)
To assess change of glucose AUC during 2H OGTT test
Measured: Baseline week4, week6 and 10 weeks
Secondary outcomes (1)
Measure of body composition (Time Frame: 10 weeks)
To assess changes in body composition (fat mass, lean body mass in Kg)
Measured: Baseline week4, week6 and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start18 Mar 2016
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- BCAA
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715010
- Sponsor's protocol ID
- 15-001928
- Status last verified
- Sep 2019
- First submitted
- 9 Oct 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woo SL, Yang J, Hsu M, Yang A, Zhang L, Lee RP, Gilbuena I, Thames G, Huang J, Rasmussen A, Carpenter CL, Henning SM, Heber D, Wang Y, Li Z. Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study. Am J Clin Nutr. 2019 Jun 1;109(6):1569-1577. doi: 10.1093/ajcn/nqz024.
PubMed 31005973
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-diabetic Subjects
- ClinicalTrials.gov ID
- NCT03715010
- Acronym / sponsor ID
- 15-001928
- Conditions
- Pre-diabetes, Obese, Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 22 Oct 2018 (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.
This study aims to determine whether the use of Branched-Chain Amino Acids (BCAA's) regulate insulin and glucagon secretion, and whether the supplement has any effect on body weight and body composition. Subjects who participate in this study will receive an 8-week supply of supplement. The study supplements will be manufactured by Scientific Living, in Irvine, CA for high dose BCAA and the low dose BCAA is manufactured by Nutribiotic, Lakeport, CA. Timed blood collections will be used to measure how BCAA affect glucose metabolism/insulin sensitivity in human subjects.
Detailed description
- BCAA's multiple functions in cells In addition to participating in de novo protein synthesis, Branched-Chain Amino Acids (BCAAs, including leucine, isoleucine, and valine) regulate multiple cellular functions as nutrient signaling. For example, BCAAs regulate insulin and glucagon secretion and thus glucose metabolism1. BCAAs, especially leucine, is one key regulator of mTOR signaling, which is the central component of a complex signaling network of insulin signaling, cell growth, and proliferation. BCAAs also regulate protein synthesis and degradation in various tissues.
- Impact of BCAA supplemental or BCAA-enriched diet on metabolism In addition to the healthcare utilization of BCAAs for liver disorders and their complications and other diseases, BCAA supplementation is common amongst athletes and fitness professionals to improve muscle building and strength. Meanwhile, BCAA supplementation or BCAA-rich protein diets are often associated with positive effects on body weight and glucose homeostasis1. Increasing dietary uptake of BCAAs improved the parameters associated with obesity and T2DM, such as body composition and glycemia levels. However, these beneficial effects are not conclusive. Moreover, other studies have shown that circulating branched-chain amino acid concentrations are associated with obesity and future insulin resistance in children and adolescents2.
- Summary Both beneficial and detrimental effects of BCAA on metabolism have been established and therefore warrants further investigation. In the preliminary study, we found that BCAAs enhanced glucose metabolism in lean mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- BCAA
| Arm | Type | Receives |
|---|---|---|
| Brain Chain Amino Acid (BCAA) | Active comparator | Dietary Supplement: BCAASubjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design |
| Placebo | Placebo comparator | Dietary Supplement: BCAASubjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-65 years of age at screen
- BMI between 27 to 40
- Fasting glucose level >100, but <126 mg/dL or HgbA1c >5.7% but < 6.4%
- Waist circumference > 40 in for men and >35 in for women
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Key exclusion criteria (7 listed)
- Any subject with a history of diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, cancer (except skin basal cell carcinoma ) chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Any subject who currently uses tobacco products.
- Any history of gastrointestinal disease except for appendectomy.
- Any antibiotic or laxative use during the 2 months before the study.
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 |
|---|---|---|
| BCAAAlso: Branch Chain Amino AcidSubjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa | Dietary supplement | Brain Chain Amino Acid (BCAA), Placebo |
Primary outcome
Measure of glucose AUC during 2H OGTT (Frame: 10 weeks)
Time frame: Baseline week4, week6 and 10 weeks
To assess change of glucose AUC during 2H OGTT test
1 secondary outcome
Measure of body composition (Time Frame: 10 weeks)
Time frame: Baseline week4, week6 and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 31005973Woo SL, Yang J, Hsu M, Yang A, Zhang L, Lee RP, Gilbuena I, Thames G, Huang J, Rasmussen A, Carpenter CL, Henning SM, Heber D, Wang Y, Li Z. Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study. Am J Clin Nutr. 2019 Jun 1;109(6):1569-1577. doi: 10.1093/ajcn/nqz024.
- 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.
Zhaoping Li, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA in people with Pre-diabetes and Obese, run by University of California, Los Angeles 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 5 inclusion and 7 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 20 Sep 2019. 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?
Measure of glucose AUC during 2H OGTT (Frame: 10 weeks) (time frame: Baseline week4, week6 and 10 weeks). 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 NCT03715010, 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 20 Sep 2019.