A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women

Conditions
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Amino Acid, Body Weight Changes, Skin Manifestations, Obesity, Postmenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopause Obesity (I class) or overweight Exclusion Criteria: Taking any medication Having liver, renal and thyroid disease Smoking Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement<br> | Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* Isocaloric formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on Visceral Adipose Tissue | Evaluation of Visceral Adipose Tissue (g) | Baseline / 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |