Body WeightNCT04317079
Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
A study testing Hydroxytyrosol and Diet in people with Body Weight and Visceral Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Visceral Obesity
- What is being tested?
- Hydroxytyrosol and Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteGreece
- Study dates
- 30 Oct 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, 11527
About this study
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
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.
Read the 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
- Body Weight, Visceral Obesity
- Being tested
- Hydroxytyrosol, Diet
- Keywords
- Hydroxytyrosol, Body weight, Visceral fat
- Medical subject headings
- Body Weight, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxytyrosolDietary supplement
Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months
DietOther
Consultation by a dietitian was offered to all participants
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Measured: Baseline, 4,12 and 24 weeks
Change in body fat mass
Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Measured: Baseline, 4,12 and 24 weeks
Change in visceral fat
Measurement via TANITA technology
Measured: Baseline, 4, 12 and 24 weeks
Secondary outcomes (3)
Changes in blood lipids
Measurement of serum total cholesterol, high-density lipoprotein and triglycerides
Measured: Baseline, 12 and 24 weeks
Changes in blood glucose
Measurement of serum glucose
Measured: Baseline, 12 and 24 weeks
Changes in blood insulin
Measurement of serum insulin
Measured: Baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start30 Oct 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
- Investigators
- Nikolaos Tentolouris, MD,PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317079
- Sponsor's protocol ID
- HydroxytyrosolStudy
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22220510Peyrol 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.
PubMed 28335507Colica 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.
PubMed 28855976
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04317079
- Acronym / sponsor ID
- HydroxytyrosolStudy
- Conditions
- Body Weight, Visceral Obesity
- Keywords
- Hydroxytyrosol, Body weight, Visceral fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 15mg of hydroxytyrosol | Active comparator | Dietary Supplement: Hydroxytyrosol, Other: Diet15 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 |
| 5mg of hydroxytyrosol | Active comparator | Dietary Supplement: Hydroxytyrosol, Other: Diet5 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 |
| placebo | Placebo comparator | Other: Diet2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxytyrosolAdministration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months | Dietary supplement | 15mg of hydroxytyrosol, 5mg of hydroxytyrosol |
| DietConsultation by a dietitian was offered to all participants | Other | 15mg of hydroxytyrosol, 5mg of hydroxytyrosol, placebo |
Primary outcome
Change in body weight
Time frame: Baseline, 4,12 and 24 weeks
Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
Change in body fat mass
Time frame: Baseline, 4,12 and 24 weeks
Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
Change in visceral fat
Time frame: Baseline, 4, 12 and 24 weeks
Measurement via TANITA technology
3 secondary outcomes
Changes in blood lipids
Time frame: Baseline, 12 and 24 weeks
Changes in blood glucose
Time frame: Baseline, 12 and 24 weeks
Changes in blood insulin
Time frame: Baseline, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Background: PubMed 22220510Cotrim 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.
- Background: PubMed 28335507Peyrol 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.
- Background: PubMed 28855976Colica 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Tentolouris, MD,PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxytyrosol and Diet in people with Body Weight and Visceral Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline, 4,12 and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.