## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** HydroxytyrosolStudy
#### Organization
**Class:** OTHER
**Full Name:** National and Kapodistrian University of Athens
### Status Module
#### Completion Date
**Date:** 2019-05-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-20

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05-15

**Type:** ACTUAL

#### Start Date
**Date:** 2017-10-30

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2020-03-20
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-19
**Study First Submit QC Date:** 2020-03-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National and Kapodistrian University of Athens

#### Responsible Party

**Investigator Affiliation:** National and Kapodistrian University of Athens

**Investigator Full Name:** Alexandros Kokkinos

**Investigator Title:** Associate Professor in Internal Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Body Weight

- Visceral Obesity

**Keywords:**

- Hydroxytyrosol

- Body weight

- Visceral fat

### Design Module

#### Design Info

**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

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 37

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Dietary Supplement: Hydroxytyrosol

- Other: Diet

**Label:** 15mg of hydroxytyrosol

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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

**Intervention Names:**

- Dietary Supplement: Hydroxytyrosol

- Other: Diet

**Label:** 5mg of hydroxytyrosol

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: Diet

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 15mg of hydroxytyrosol

- 5mg of hydroxytyrosol

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

**Name:** Hydroxytyrosol

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- 15mg of hydroxytyrosol

- 5mg of hydroxytyrosol

- placebo

**Description:** Consultation by a dietitian was offered to all participants

**Name:** Diet

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology

**Measure:** Change in body weight

**Time Frame:** Baseline, 4,12 and 24 weeks

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

**Measure:** Change in body fat mass

**Time Frame:** Baseline, 4,12 and 24 weeks

**Description:** Measurement via TANITA technology

**Measure:** Change in visceral fat

**Time Frame:** Baseline, 4, 12 and 24 weeks

#### Secondary Outcomes

**Description:** Measurement of serum total cholesterol, high-density lipoprotein and triglycerides

**Measure:** Changes in blood lipids

**Time Frame:** Baseline, 12 and 24 weeks

**Description:** Measurement of serum glucose

**Measure:** Changes in blood glucose

**Time Frame:** Baseline, 12 and 24 weeks

**Description:** Measurement of serum insulin

**Measure:** Changes in blood insulin

**Time Frame:** Baseline, 12 and 24 weeks

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 66 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Athens

**Country:** Greece

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

**Zip:** 11527

#### Overall Officials

**Official 1:**

**Affiliation:** National Kapodistrian University of Athens

**Name:** Nikolaos Tentolouris, MD,PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 22220510

**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.

**PMID:** 28335507

**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.

**PMID:** 28855976

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000009765

- Term: Obesity

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Body Weight

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M28427

- Name: Obesity, Abdominal

- Relevance: HIGH

- As Found: Visceral Obesity

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

- ID: D000056128

- Term: Obesity, Abdominal

- ID: D000001835

- Term: Body Weight

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M108425

- Name: 3,4-dihydroxyphenylethanol

- Relevance: HIGH

- As Found: SLS

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000005975

- Term: 3,4-dihydroxyphenylethanol

### Misc Info Module

- Version Holder: 2024-05-24
