Clinical trial NCT04317079: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Visceral Obesity
Keywords: Hydroxytyrosol
Body weight
Visceral fat
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 4,12 and 24 weeks
measure: Change in body fat mass
timeFrame: Baseline, 4,12 and 24 weeks
measure: Change in visceral fat
timeFrame: Baseline, 4, 12 and 24 weeks
Secondary outcomes:
measure: Changes in blood lipids
timeFrame: Baseline, 12 and 24 weeks
measure: Changes in blood glucose
timeFrame: Baseline, 12 and 24 weeks
measure: Changes in blood insulin
timeFrame: Baseline, 12 and 24 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Study officials:
affiliation: National Kapodistrian University of Athens
name: Nikolaos Tentolouris, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.