Amino Acid, Body Weight Changes, Obesity, Postmenopausal Disorder, Skin Manifestations
Conditions
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.
Interventions
DIETARY_SUPPLEMENTL-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_PRODUCTPlacebo
Isocaloric formula
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Visceral Adipose Tissue | Baseline / 30 days | Evaluation of Visceral Adipose Tissue (g) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Body Composition | Baseline / 30 days | Evaluation of fat mass and fat free mass (g) |
| Changes on Metabolic parameters | Baseline / 30 days | 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) |
| Changes on anthropometric measurements | Baseline / 30 days | Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2) |
| Changes on skin condition | Baseline / 30 days | 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. |
Countries
Italy
Outcome results
None listed