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The use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (FSMP) for muscle recovery, consisting of arginine, glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate | Dietary Supplement | 2 daily sachets (mid morning and mid afternoon) of an oral dietary supplement with L-glutamine and L-arginine and calcium beta-hydroxy-beta-methylbutyrate |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on Visceral Adipose Tissue | Evaluation of Visceral Adipose Tissue (g) | Baseline / 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on Body Composition | Evaluation of fat mass and fat free mass (g) | Baseline / 30 days |
| Changes on Metabolic parameters | Evaluation of Fasting blood glucose (mg/dl), total cholesterol (mg/dl), low-density lipoprotein-cholesterol (mg/dl), high-density lipoprotein-cholesterol (mg/dl) and triglyceride levels (mg/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona | Pavia | 27100 | Italy |
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| Placebo | Combination Product | Isocaloric formula |
|
| Baseline / 30 days |
| Changes on Metabolic parameters | Evaluation of insulin (mcIU/mL) | Baseline / 30 days |
| Changes on Metabolic parameters | Evaluation of insulin resistance (HOMA index) | Baseline / 30 days |
| Changes on anthropometric measurements | Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2) | Baseline / 30 days |
| Changes on anthropometric measurements | Evaluation of waist circumference (cm) | Baseline / 30 days |
| Changes on skin condition | Administration of a questionnaire survey with a point evaluation scale from 0 to 5 (Oe et al, 2017). For the skin luster and suppleness, one is the worst and five is the best. For the wrinkles, one is least wrinkles; not worry, and five is most wrinkles; most care. | Baseline / 30 days |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D012877 | Skin Manifestations |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D021542 | Amino Acids, Neutral |
| D000601 | Amino Acids, Essential |
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