Skip to content

Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women

Evaluation of the Effects of the Administration of 5 Milligrams and 15 Milligrams of Hydroxytyrosol, an Extra Virgin Olive Oil Phenolic Compound, Versus Placebo, Combined With Diet, in Anthropometric Parameters in Overweight and Obese Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04317079
Enrollment
37
Registered
2020-03-20
Start date
2017-10-30
Completion date
2019-05-15
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Visceral Obesity

Keywords

Hydroxytyrosol, Body weight, Visceral fat

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.

Interventions

DIETARY_SUPPLEMENTHydroxytyrosol

Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months

OTHERDiet

Consultation by a dietitian was offered to all participants

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Administration of hydroxytyrosol (15mg versus 5 mg daily) versus placebo for 6 months in combination with diet in order to assess effects in body weight, body fat mass and visceral fat mass loss

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 66 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body weightBaseline, 4,12 and 24 weeksMeasurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Change in body fat massBaseline, 4,12 and 24 weeksMeasurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Change in visceral fatBaseline, 4, 12 and 24 weeksMeasurement via TANITA technology

Secondary

MeasureTime frameDescription
Changes in blood lipidsBaseline, 12 and 24 weeksMeasurement of serum total cholesterol, high-density lipoprotein and triglycerides
Changes in blood glucoseBaseline, 12 and 24 weeksMeasurement of serum glucose
Changes in blood insulinBaseline, 12 and 24 weeksMeasurement of serum insulin

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026