search
Back to results

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

Primary Purpose

Body Weight, Visceral Obesity

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Hydroxytyrosol
Diet
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight focused on measuring Hydroxytyrosol, Body weight, Visceral fat

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

15mg of hydroxytyrosol

5mg of hydroxytyrosol

placebo

Arm Description

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

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

2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet

Outcomes

Primary Outcome Measures

Change in body weight
Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Change in body fat mass
Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Change in visceral fat
Measurement via TANITA technology

Secondary Outcome Measures

Changes in blood lipids
Measurement of serum total cholesterol, high-density lipoprotein and triglycerides
Changes in blood glucose
Measurement of serum glucose
Changes in blood insulin
Measurement of serum insulin

Full Information

First Posted
March 19, 2020
Last Updated
March 19, 2020
Sponsor
National and Kapodistrian University of Athens
search

1. Study Identification

Unique Protocol Identification Number
NCT04317079
Brief Title
Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Visceral Obesity
Keywords
Hydroxytyrosol, Body weight, Visceral fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15mg of hydroxytyrosol
Arm Type
Active Comparator
Arm Description
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
Arm Title
5mg of hydroxytyrosol
Arm Type
Active Comparator
Arm Description
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
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydroxytyrosol
Intervention Description
Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Consultation by a dietitian was offered to all participants
Primary Outcome Measure Information:
Title
Change in body weight
Description
Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Time Frame
Baseline, 4,12 and 24 weeks
Title
Change in body fat mass
Description
Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Time Frame
Baseline, 4,12 and 24 weeks
Title
Change in visceral fat
Description
Measurement via TANITA technology
Time Frame
Baseline, 4, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Changes in blood lipids
Description
Measurement of serum total cholesterol, high-density lipoprotein and triglycerides
Time Frame
Baseline, 12 and 24 weeks
Title
Changes in blood glucose
Description
Measurement of serum glucose
Time Frame
Baseline, 12 and 24 weeks
Title
Changes in blood insulin
Description
Measurement of serum insulin
Time Frame
Baseline, 12 and 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Tentolouris, MD,PhD
Organizational Affiliation
National Kapodistrian University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
City
Athens
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22220510
Citation
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.
Results Reference
background
PubMed Identifier
28335507
Citation
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.
Results Reference
background
PubMed Identifier
28855976
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs