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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-11-25

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.

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Detailed Description

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Conditions

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Amino Acid Body Weight Changes Skin Manifestations Obesity Postmenopausal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement

Group Type EXPERIMENTAL

L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

Intervention Type 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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Isocaloric formula

Interventions

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L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Isocaloric formula

Intervention Type COMBINATION_PRODUCT

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)

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes