An interventional study of L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate and Placebo in Amino Acid, Body Weight Changes and Skin Manifestations, sponsored by Azienda di Servizi alla Persona di Pavia. Completed at 1 site in Italy. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Azienda di Servizi alla Persona di Pavia · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 20 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Exclusion Criteria:
Dietary Supplement: L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate
Combination Product: Placebo
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
Isocaloric formula
Changes on Visceral Adipose Tissue
Evaluation of Visceral Adipose Tissue (g)
Time frame: Baseline / 30 days
Changes on Body Composition
Evaluation of fat mass and fat free mass (g)
Time frame: Baseline / 30 days
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)
Time frame: Baseline / 30 days
Changes on Metabolic parameters
Evaluation of insulin (mcIU/mL)
Time frame: Baseline / 30 days
Changes on Metabolic parameters
Evaluation of insulin resistance (HOMA index)
Time frame: Baseline / 30 days
Changes on anthropometric measurements
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Time frame: Baseline / 30 days
Changes on anthropometric measurements
Evaluation of waist circumference (cm)
Time frame: Baseline / 30 days
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.
Time frame: Baseline / 30 days
Plan to share: No
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Azienda di Servizi alla Persona di Pavia