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| Name | Class |
|---|---|
| Ajinomoto Co., Inc. | INDUSTRY |
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The purpose of this study is to determine whether consuming additional leucine during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight maintenance | No Intervention | Weight maintenance with normal protein and leucine intake | |
| Weight loss with normal protein intake | Active Comparator |
| |
| Weight loss with leucine supplementation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss with normal protein and leucine intake | Behavioral | Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle mass | We will measure total appendicular skeletal muscle mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI) | Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
| Change in muscle strength | We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests. | Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
| Change in bone mineral density and bone mineral content | We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA). | Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skeletal muscle insulin sensitivity | We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions | Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25475435 | Result | Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4. | |
| 28473464 | Derived | Harris LLS, Smith GI, Patterson BW, Ramaswamy RS, Okunade AL, Kelly SC, Porter LC, Klein S, Yoshino J, Mittendorfer B. Alterations in 3-Hydroxyisobutyrate and FGF21 Metabolism Are Associated With Protein Ingestion-Induced Insulin Resistance. Diabetes. 2017 Jul;66(7):1871-1878. doi: 10.2337/db16-1475. Epub 2017 May 4. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010024 | Osteoporosis |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Weight loss with protein/leucine supplementation | Behavioral | Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content. |
|
| Change in bacterial populations found in the stool |
| Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
| Change in cell proliferation (growth) rates in the colon | We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples | Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group |
| Determine the acute effect of leucine ingestion on skeletal muscle insulin sensitivity | We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions | Prior to starting the weight loss or maintenance intervention |
| Determine the acute effect of leucine ingestion on muscle protein metabolism | We will assess rates of muscle protein synthesis, breakdown and net protein balance using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without leucine ingestion. | Prior to starting the weight loss or maintenance intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |