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

January 7, 2021 updated by: Azienda di Servizi alla Persona di Pavia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Azienda di Servizi alla Persona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination product: Placebo
Isocaloric formula
Experimental: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on Body Composition
Time Frame: Baseline / 30 days
Evaluation of fat mass and fat free mass (g)
Baseline / 30 days
Changes on Metabolic parameters
Time Frame: Baseline / 30 days
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
Time Frame: Baseline / 30 days
Evaluation of insulin (mcIU/mL)
Baseline / 30 days
Changes on Metabolic parameters
Time Frame: Baseline / 30 days
Evaluation of insulin resistance (HOMA index)
Baseline / 30 days
Changes on anthropometric measurements
Time Frame: Baseline / 30 days
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Baseline / 30 days
Changes on anthropometric measurements
Time Frame: Baseline / 30 days
Evaluation of waist circumference (cm)
Baseline / 30 days
Changes on skin condition
Time Frame: Baseline / 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda di Servizi alla Persona di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

November 3, 2020

Study Completion (Actual)

November 25, 2020

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0912/14122018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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