Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
- Conditions
- Body WeightVisceral Obesity
- Interventions
- Dietary Supplement: HydroxytyrosolOther: Diet
- Registration Number
- NCT04317079
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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 placebo for 6 months in anthropometric parameters such as body weight, body fat and visceral fat, in combination with diet, in overweight and obese women.
- 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, and hydroxytyrosol could have a potential role in this.
Participants entered the study after signing the informed consent document. Detailed medical and family history was taken at baseline visit, and measurement of height, body weight, body fat and visceral fat were also made. Each participant visited a dietitian the same day and written consultation concerning the diet to be followed was given, based on Mediterranean diet and 500 kilocalories below their estimated Basal Metabolic Rate. The above measurements and dietitian consultation were repeated in each visit during the intervention (4,12 and 24 weeks).
Baseline laboratory testing was made including urea, creatinine, aminotransferases and fasting lipids and glucose, while serum and plasma were stored in -80 Celsius degrees for future analyses. Blood samples were also taken at 4, 12 and 24 weeks of the intervention.
All participants had an identical meal test at baseline, at 12 and 24 months and blood samples were collected at times 0, 30, 60, 90, 120, 150 and 180 minutes after meal consumption. Samples were also stored in -80 Celsius degrees for future analyses.
Each participant received in each visit prepackaged the quantity of capsules until the next scheduled visit, and the used empty blisters were returned in the following visit in order to assess compliance in capsules consumption. 24-hour diet recalls were used to assess compliance to diet.
In each visit an investigation concerning potential adverse events was made and data were recorded.
A communication was obtained with each participant who discontinued the study before 24 weeks, the reasons for discontinuation were recorded and data obtained until their last visit before study discontinuation were used in analyses.
Paired analyses were made using the system Statistical Package for the Social Sciences comparing all study groups before and after the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 37
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5mg of hydroxytyrosol 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 15mg of hydroxytyrosol Hydroxytyrosol 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 15mg of hydroxytyrosol Diet 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 placebo Diet 2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet 5mg of hydroxytyrosol Hydroxytyrosol 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
- Primary Outcome Measures
Name Time Method Change in body fat mass Baseline, 4,12 and 24 weeks Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Change in body weight Baseline, 4,12 and 24 weeks Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Change in visceral fat Baseline, 4, 12 and 24 weeks Measurement via TANITA technology
- Secondary Outcome Measures
Name Time Method Changes in blood insulin Baseline, 12 and 24 weeks Measurement of serum insulin
Changes in blood lipids Baseline, 12 and 24 weeks Measurement of serum total cholesterol, high-density lipoprotein and triglycerides
Changes in blood glucose Baseline, 12 and 24 weeks Measurement of serum glucose
Trial Locations
- Locations (1)
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
🇬🇷Athens, Greece