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

NCT04701463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-08

No results posted yet for this study

Summary

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.

Conditions

  • Amino Acid
  • Body Weight Changes
  • Skin Manifestations
  • Obesity
  • Postmenopausal Disorder

Interventions

DIETARY_SUPPLEMENT

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

COMBINATION_PRODUCT

Placebo

Isocaloric formula

Sponsors & Collaborators

  • Azienda di Servizi alla Persona di Pavia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-11-03
Completion
2020-11-25

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701463 on ClinicalTrials.gov