Azienda di Servizi alla Persona
Pavia, 27100, Italy
NCT Number: NCT04701463
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.
Looking for future studies?
Notify Me45 year–65 year
Female
Interventional
Not applicable
Pavia, 27100, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline / 30 days
Evaluation of Visceral Adipose Tissue (g)
Time frame: Baseline / 30 days
Evaluation of fat mass and fat free mass (g)
Time frame: 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)
Time frame: Baseline / 30 days
Evaluation of insulin (mcIU/mL)
Time frame: Baseline / 30 days
Evaluation of insulin resistance (HOMA index)
Time frame: Baseline / 30 days
Evaluation of body weight (kg) and height (m) combined for Body Mass Index (kg/m2)
Time frame: Baseline / 30 days
Evaluation of waist circumference (cm)
Time frame: 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.
Azienda di Servizi alla Persona di Pavia
Other
Effect of a Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Sedentary Postmenopausal Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03409380
Amino Acid, Arginine
Baton Rouge, Louisiana, United States
View Trial DetailsNCT05412667
Amino Acid, Behavior
Taoyuan, Taiwan
View Trial DetailsNCT03279211
Amino Acid
Bobigny, France
View Trial DetailsNCT01540773
Amino Acid, Growth Hormone
Baton Rouge, Louisiana, United States
View Trial Details