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

NCT04317079 | Completed

• 1 other identifier: HydroxytyrosolStudy
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight; Visceral Obesity

Keywords

Hydroxytyrosol; Body weight; Visceral fat

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Changes in blood lipids

  Baseline, 12 and 24 weeks

• Changes in blood glucose

  Baseline, 12 and 24 weeks

• Changes in blood insulin

  Baseline, 12 and 24 weeks

Study Arms (3)

15mg of hydroxytyrosol

ACTIVE COMPARATOR

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; Other: Diet

5mg of hydroxytyrosol

ACTIVE COMPARATOR

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; Other: Diet

placebo

PLACEBO COMPARATOR

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

Other: Diet

Interventions

Hydroxytyrosol DIETARY_SUPPLEMENT

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

15mg of hydroxytyrosol; 5mg of hydroxytyrosol

Diet OTHER

Consultation by a dietitian was offered to all participants

15mg of hydroxytyrosol; 5mg of hydroxytyrosol; placebo

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

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

Athens, 11527, Greece

Location

Related Publications (3)

• 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.

  PMID: 22220510 BACKGROUND

• 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.

  PMID: 28335507 BACKGROUND

• 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.

  PMID: 28855976 BACKGROUND

MeSH Terms

Conditions

Body Weight; Obesity, Abdominal

Interventions

3,4-dihydroxyphenylethanol; Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nikolaos Tentolouris, MD,PhD

  National Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Internal Medicine

Model Details: 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

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: October 30, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)