Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People (NCT02837367) | Clinical Trial Compass
UnknownNot Applicable
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
Romania600 participantsStarted 2016-09
Plain-language summary
The NutriGen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.
Who can participate
Age range7 Years – 70 Years
SexALL
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Inclusion Criteria:
* Adults: between 18 and 70 years old; obesity present as defined by body mass index (BMI) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum Cholesterol ≥200 mg/dl, HDLc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum Triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe).
* Children: age between 7 and 18 years old; BMI \>+2SD WHO reference
Exclusion Criteria:
* Adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using AUDIT-C.
* Children: the above exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (Cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (Babinski-Fröhlich syndrome), genetic syndromes (Prader-Willi, achondroplasia, Bardet-Biedl, Fanconi, Turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.
What they're measuring
1
Lipid profile
Timeframe: 3 years
Trial details
NCT IDNCT02837367
SponsorUniversity of Medicine and Pharmacy "Victor Babes" Timisoara