Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
Body Weight, Visceral Obesity
About this trial
This is an interventional treatment trial for Body Weight focused on measuring Hydroxytyrosol, Body weight, Visceral fat
Eligibility Criteria
Inclusion Criteria:
Overweight and obese women. Stable body weight (<5% variation) during the past 3 months before enrollment. Stable hypolipidemic treatment for at least 3 months before enrollment.
Exclusion Criteria:
- Diabetes mellitus
- Neoplasms
- Autoimmune conditions
- Psychiatric disorders (excluding stable depressive disorder)
- Hyper/hypo-thyroidism with recent changes in medical treatment during the past 6 months before enrollment
- Renal impairment, defined as estimated Glomerular Filtration Rate (MDRD) <60millilitres/min
- Heart failure, defined as left ventricle Ejection Fraction <40%, use of diuretics or other treatment due to heart failure (antihypertensive medications allowed)
- Impaired liver function, defined as liver transaminases values twice above the upper normal range
- Malabsorption status (inflammatory bowel disease, previous bariatric surgery, chronic pancreatitis)
- Medical treatment known to influence body weight (steroids, oestrogens/ progesterone, topiramate, mirtazapine or anti-obesity treatment)
- Unwillingness to participate to the study
- Baseline waist circumference >130cm due to technical difficulties in visceral fat measurement
- Pregnancy, lactation
Sites / Locations
- Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
15mg of hydroxytyrosol
5mg of hydroxytyrosol
placebo
15 milligrams of hydroxytyrosol given as 2 capsules containing 2.5mg of hydroxytyrosol each given three times daily before main meals (totally 6 capsules daily) in combination with diet
5 milligrams of hydroxytyrosol given as 2 capsules containing 2.5mg of hydroxytyrosol each given in the morning and at night before meals and 2 capsules of placebo before lunch (totally 6 capsules daily) in combination with diet
2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet