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

Primary Purpose

Amino Acid, Body Weight Changes, Skin Manifestations

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
Placebo
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amino Acid

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Azienda di Servizi alla Persona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes on Visceral Adipose Tissue
Evaluation of Visceral Adipose Tissue (g)

Secondary Outcome Measures

Changes on Body Composition
Evaluation of fat mass and fat free mass (g)
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)
Changes on Metabolic parameters
Evaluation of insulin (mcIU/mL)
Changes on Metabolic parameters
Evaluation of insulin resistance (HOMA index)
Changes on anthropometric measurements
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Changes on anthropometric measurements
Evaluation of waist circumference (cm)
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.

Full Information

First Posted
January 5, 2021
Last Updated
January 7, 2021
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04701463
Brief Title
A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women
Official Title
Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amino Acid, Body Weight Changes, Skin Manifestations, Obesity, Postmenopausal Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
Intervention Description
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
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Isocaloric formula
Primary Outcome Measure Information:
Title
Changes on Visceral Adipose Tissue
Description
Evaluation of Visceral Adipose Tissue (g)
Time Frame
Baseline / 30 days
Secondary Outcome Measure Information:
Title
Changes on Body Composition
Description
Evaluation of fat mass and fat free mass (g)
Time Frame
Baseline / 30 days
Title
Changes on Metabolic parameters
Description
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)
Time Frame
Baseline / 30 days
Title
Changes on Metabolic parameters
Description
Evaluation of insulin (mcIU/mL)
Time Frame
Baseline / 30 days
Title
Changes on Metabolic parameters
Description
Evaluation of insulin resistance (HOMA index)
Time Frame
Baseline / 30 days
Title
Changes on anthropometric measurements
Description
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Time Frame
Baseline / 30 days
Title
Changes on anthropometric measurements
Description
Evaluation of waist circumference (cm)
Time Frame
Baseline / 30 days
Title
Changes on skin condition
Description
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.
Time Frame
Baseline / 30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Azienda di Servizi alla Persona
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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