NCT04701463

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Azienda di Servizi alla Persona di Pavia · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-01-15
• Primary completion: 2020-11-03
• Completion: 2020-11-25
• First posted: 2021-01-08
• Last updated: 2021-01-08

Locations

1 site across 1 country: Italy