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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04701463
Other study ID # 0912/14122018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date November 25, 2020

Study information

Verified date January 2021
Source Azienda di Servizi alla Persona di Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 25, 2020
Est. primary completion date November 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Italy Azienda di Servizi alla Persona Pavia

Sponsors (1)

Lead Sponsor Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes on Visceral Adipose Tissue Evaluation of Visceral Adipose Tissue (g) Baseline / 30 days
Secondary Changes on Body Composition Evaluation of fat mass and fat free mass (g) Baseline / 30 days
Secondary 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) Baseline / 30 days
Secondary Changes on Metabolic parameters Evaluation of insulin (mcIU/mL) Baseline / 30 days
Secondary Changes on Metabolic parameters Evaluation of insulin resistance (HOMA index) Baseline / 30 days
Secondary Changes on anthropometric measurements Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2) Baseline / 30 days
Secondary Changes on anthropometric measurements Evaluation of waist circumference (cm) Baseline / 30 days
Secondary 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. Baseline / 30 days
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