Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 50 |
| Updated: | 2/14/2018 |
| Start Date: | October 2016 |
| End Date: | February 2018 |
Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on
metabolism have been established and therefore warrants further investigation. In the
preliminary study, the investigators 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.
This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking
BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and
will have an oral glucose tolerance test on repeated occasions to see if any changes are
noted in their glucose regulation.
metabolism have been established and therefore warrants further investigation. In the
preliminary study, the investigators 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.
This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking
BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and
will have an oral glucose tolerance test on repeated occasions to see if any changes are
noted in their glucose regulation.
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.
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
adolescents.
This is a 12-week, randomized, crossover study with 10 obese subjects with prediabetes.
Subjects will be randomly assigned to take 20g BCAA or low-BCAA protein a day for 4 weeks,
then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.
At baseline and weeks 4, 6 and 10 weeks glucose, insulin and triglyceride levels will be
tested at time 0, 30 min, 60 min, and 120 min after 75 grams of glucose load. In addition to
laboratory tests vital signs, weight and body composition will be done.
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.
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
adolescents.
This is a 12-week, randomized, crossover study with 10 obese subjects with prediabetes.
Subjects will be randomly assigned to take 20g BCAA or low-BCAA protein a day for 4 weeks,
then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.
At baseline and weeks 4, 6 and 10 weeks glucose, insulin and triglyceride levels will be
tested at time 0, 30 min, 60 min, and 120 min after 75 grams of glucose load. In addition to
laboratory tests vital signs, weight and body composition will be done.
Inclusion Criteria:
1. Age 20-50 years of age at screen
2. BMI between 27 to 35
3. Fasting glucose level >100, but <126 mg/dL or HgbA1c >5.7% but < 6.4%
4. Waist circumference > 40 cm in men and >35 in women
5. 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.
Exclusion Criteria:
1. 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.
2. Any subject with a screening laboratory value outside of the laboratory normal range
that is considered clinically significant for study participation by the investigator.
3. Any subject who currently uses tobacco products.
4. Any history of gastrointestinal disease except for appendectomy.
5. Any antibiotic or laxative use during the 2 months before the study.
6. Any subject who is unable or unwilling to comply with the study protocol.
7. Any subject allergic to soy products.
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