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

Not Applicable

Completed

• Conditions: Amino Acid; Body Weight Changes; Obesity; Skin Manifestations; Postmenopausal Disorder
• Interventions: Combination Product: Placebo; Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

• Registration Number: NCT04701463
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-15
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-25
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate supplement	L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate	-

Primary Outcome Measures

Name	Time	Method
Changes on Visceral Adipose Tissue	Baseline / 30 days	Evaluation of Visceral Adipose Tissue (g)

Secondary Outcome Measures

Name	Time	Method
Changes on Body Composition	Baseline / 30 days	Evaluation of fat mass and fat free mass (g)
Changes on Metabolic parameters	Baseline / 30 days	Evaluation of insulin resistance (HOMA index)
Changes on anthropometric measurements	Baseline / 30 days	Evaluation of waist circumference (cm)
Changes on skin condition	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.

Trial Locations

Locations (1)

Azienda di Servizi alla Persona; 🇮🇹 Pavia, Italy