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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight; Visceral Obesity
• Intervention / Treatment: Dietary supplement: Hydroxytyrosol; Other: Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 15mg of 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	Dietary supplement: Hydroxytyrosol; Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months; Other: Diet; Consultation by a dietitian was offered to all participants
Active Comparator: 5mg of 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	Dietary supplement: Hydroxytyrosol; Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months; Other: Diet; Consultation by a dietitian was offered to all participants
Placebo Comparator: placebo; 2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet	Other: Diet; Consultation by a dietitian was offered to all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology	Baseline, 4,12 and 24 weeks
Change in body fat mass	Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)	Baseline, 4,12 and 24 weeks
Change in visceral fat	Measurement via TANITA technology	Baseline, 4, 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood lipids	Measurement of serum total cholesterol, high-density lipoprotein and triglycerides	Baseline, 12 and 24 weeks
Changes in blood glucose	Measurement of serum glucose	Baseline, 12 and 24 weeks
Changes in blood insulin	Measurement of serum insulin	Baseline, 12 and 24 weeks

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens
• Investigators: Principal Investigator: Nikolaos Tentolouris, MD,PhD, National Kapodistrian University of Athens

Publications and helpful links

General Publications

• Cotrim BA, Joglar J, Rojas MJ, del Olmo JM, Macias-Gonzalez M, Cuevas MR, Fito M, Munoz-Aguayo D, Planells MI, Farre M, de Fonseca FR, de la Torre R. Unsaturated fatty alcohol derivatives of olive oil phenolic compounds with potential low-density lipoprotein (LDL) antioxidant and antiobesity properties. J Agric Food Chem. 2012 Feb 1;60(4):1067-74. doi: 10.1021/jf203814r. Epub 2012 Jan 20.
• Peyrol J, Riva C, Amiot MJ. Hydroxytyrosol in the Prevention of the Metabolic Syndrome and Related Disorders. Nutrients. 2017 Mar 20;9(3):306. doi: 10.3390/nu9030306.
• Colica C, Di Renzo L, Trombetta D, Smeriglio A, Bernardini S, Cioccoloni G, Costa de Miranda R, Gualtieri P, Sinibaldi Salimei P, De Lorenzo A. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial. Oxid Med Cell Longev. 2017;2017:2473495. doi: 10.1155/2017/2473495. Epub 2017 Aug 9.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Hydroxytyrosol; Body weight; Visceral fat
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Overweight; Body Weight; Obesity, Abdominal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; 3,4-dihydroxyphenylethanol
• Other Study ID Numbers: HydroxytyrosolStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No