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

NCT04701463 | Completed

• 1 other identifier: 0912/14122018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Changes on Visceral Adipose Tissue

  Evaluation of Visceral Adipose Tissue (g)

  Baseline / 30 days

Secondary Outcomes (7)

• Changes on Body Composition

  Baseline / 30 days

• Changes on Metabolic parameters

  Baseline / 30 days

• Changes on Metabolic parameters

  Baseline / 30 days

• Changes on Metabolic parameters

  Baseline / 30 days

• Changes on anthropometric measurements

  Baseline / 30 days

Study Arms (2)

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

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

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

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

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

Placebo COMBINATION_PRODUCT

Isocaloric formula

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopause
• Obesity (I class) or overweight

You may not qualify if:

• Taking any medication
• Having liver, renal and thyroid disease
• Smoking
• Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Body Weight Changes; Skin Manifestations; Obesity

Interventions

Glutamine; Arginine

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: January 15, 2020
• Primary Completion: November 3, 2020
• Study Completion: November 25, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)