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

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Postmenopausal Disorder; Skin Manifestations; Obesity; Amino Acid; Body Weight Changes

Treatments: Combination Product: Placebo; Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04701463

0912/14122018

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

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

Experimental group

Treatment:

Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate

Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo