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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701463
• Other study ID #: 0912/14122018
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Amino Acid
• Body Weight
• Body Weight Changes
• Obesity
• Overweight
• Postmenopausal Disorder
• Skin Manifestations

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