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Clinical Trials/NCT04317079
NCT04317079CompletedNot Applicable

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

National and Kapodistrian University of Athens2 sites in 1 country37 target enrollmentStarted: October 30, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
37
Locations
2
Primary Endpoint
Change in body weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 66 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

Change in body weight

Time Frame: Baseline, 4,12 and 24 weeks

Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology

Change in body fat mass

Time Frame: Baseline, 4,12 and 24 weeks

Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)

Change in visceral fat

Time Frame: Baseline, 4, 12 and 24 weeks

Measurement via TANITA technology

Secondary Outcomes

  • Changes in blood insulin(Baseline, 12 and 24 weeks)
  • Changes in blood lipids(Baseline, 12 and 24 weeks)
  • Changes in blood glucose(Baseline, 12 and 24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexandros Kokkinos

Associate Professor in Internal Medicine

National and Kapodistrian University of Athens

Study Sites (2)

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