Status:
COMPLETED
Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Body Weight
Visceral Obesity
Eligibility:
FEMALE
18-66 years
Phase:
NA
Brief Summary
This study aims to investigate the potential effects of the administration of hydroxytyrosol, which is an extra virgin olive oil phenolic compound, in doses 15 milligrams and 5 milligrams daily versus...
Detailed Description
Hydroxytyrosol is an extra virgin olive oil phenolic compound which has known protective effects in LDL oxidation and reduces oxidative stress. Olive oil has been associated with enhanced weight loss,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04317079
Start Date
October 30 2017
End Date
May 15 2019
Last Update
March 20 2020
Active Locations (1)
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1
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, Greece, 11527