Condition category
Circulatory System
Date applied
20/06/2018
Date assigned
16/07/2018
Last edited
10/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The most prevalent disease in adults is hypertension (high blood pressure). The guidelines propose to start treatment in primary care with healthy lifestyle advice and medication if blood pressure is not normalized or the patient has a high cardiovascular (heart disease) risk. The olive leaf contains oleuropein, which has traditionally been used to lower blood pressure. The aim of this study is to measure blood pressure in adults with hypertension treated with olive leaf extract.

Who can participate?
Patients aged 25-65 with hypertension

What does the study involve?
Participants are randomly allocated to take either two placebo (dummy) tablets once daily or two tablets of olive leaf extract once daily for 30 days, followed by a 15-day break, after which they take the other tablets for 30 days. Blood pressure is measured before and after each treatment period. A blood sample is taken before the first treatment period, during the 15-day break, and after the second treatment period. Each participant is asked on a weekly basis about the palatability of the tablets.

What are the possible benefits and risks of participating?
No direct benefits are expected for the participants. It is possible that the blood pressure measurement provides useful information for the subsequent treatment of these patients. Some cases of mild digestive intolerance and bitter taste have been reported with olive leaf extract. There is no serious risk to health.

Where is the study run from?
CAP Ernest lluch (Spain)

When is the study starting and how long is it expected to run for?
February 2017 to November 2018

Who is funding the study?
METHARISC Group

Who is the main contact?
1. Prof. Gabriel Coll de Tuero
gcolld@comg.cat
2. Ms Rufina Espín Sanchez
st525357@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gabriel Coll de Tuero

ORCID ID

http://orcid.org/0000-0001-7578-9569

Contact details

Maluquer Salvador,11
Girona
17002
Spain
+34 (0)972421498
gcolld@comg.cat

Type

Scientific

Additional contact

Ms Rufina Espín Sanchez

ORCID ID

http://orcid.org/0000-0002-8873-3465

Contact details

Canigó,9
Vilamalla
17469
Spain
+34 (0)677871273
st525357@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

P17/038

Study information

Scientific title

Mild hypertension treated with olive leaf extract clinical trial

Acronym

N/A

Study hypothesis

1. The treatment of mild essential hypertension (HT) with a brief advice on healthy lifestyle and leaf olive extract at doses recommended by the European Medicines Agency (EMA) will reduce the systolic and diastolic blood pressure significantly.
2. The treatment of the Mild HT with a brief advice on lifestyle modifications and olive leaf extract will allow a better control of blood pressure in a higher percentage than the group that receives only brief advice about lifestyle modifications.

Ethics approval

Clinical Ethics Committee of the IDIAP Jordi Gol and Gurina, 27/09/2017, Protocol P17/038

Study design

Randomized cross over double-blind trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Hypertension

Intervention

From the population of Figueres city a sample population of 48 individuals will be extracted, by simple random sampling, these will be randomized into two groups A and B:

A. OLE, marketed under the name Olive Oil extract 20% (oleuropein Sura Vitasan 60 capsules, containing 1000 mg extract and 20% oraloleic)
B. Placebo with the same appearance

Each of the participants will receive 2 placebo tablets each day (once daily) or 2 tablets of active principle each day (once daily) of olive leaf extract with 20% oleuropein (1000 mg). Each participant will take the active treatment or placebo for 30 days, followed by a 15-day washout period, after which they will take placebo or active treatment. Each participant will be randomized to start the first period with placebo or active treatment.

A blood sample analysis will be done before the 1st exposure, during the washout period (intermediate), and after the 2nd exposure has finished. Each participant will be asked on a weekly basis for their palatability.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Ambulatory blood pressure (in mmHg) measured at the beginning and end of each treatment period (placebo or active treatment)

Secondary outcome measures

Hypertension control (BP < 140/90 mmHg; in percentage) measured at the beginning and end of each treatment period (placebo or active treatment)

Overall trial start date

10/02/2017

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Men and women aged 25-65
2. Diagnosed with essential hypertension grade 1
3. Without allergy to the components of the leaf extract of the olive or the capsule
4. Low CV risk
5. Who don't take hypertension treatment a month before inclusion
6. Do not have a target organ lesion and/or chronic illnesses (kidney, respiratory, cardiac, liver, haematological, infectious, etc) according to the European Guide for the management of the HTA ESH ESC 2013
7. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48 participants

Participant exclusion criteria

1. People with HTA grade 2 and 3
2. Grade 1 with a moderate CV risk, or high or very high according to the ESH-ESC 2013 Guidelines
3. With LOD or with subclinical vascular disease
4. With cognitive or idiomatic difficulty in fulfilling the instructions
5. Having chronic illnesses
6. Taking treatments that interfere or contraindicate the administration of the components of the olive leaf
7. Lactose intolerance
8. Pregnancy or breastfeeding

Recruitment start date

15/06/2018

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Spain

Trial participating centre

CAP Ernest lluch
Figueres
17600
Spain

Sponsor information

Organisation

Institut Universitari d'Investigació en Atenció primària Jordi Gol i Gorina (IdIAP)

Sponsor details

Gran Via de les Corts Catalanes,591 Atic
Barcelona
08007
Spain
+34 (0)934824124
idiap@idiapjgol.org

Sponsor type

Research organisation

Website

Funders

Funder type

Other

Funder name

METHARISC Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of the trial will be published in international journals in the second quarter of 2019. The results will also be presented at national (Spanish Society of hypertension) and International (European Society of Hypertension) congresses.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from Rufina Espín (st525357@gmail.com) from January 2019. The data will always be provided anonymized for reviews or meta-analysis whenever the principal investigators consider it appropriate. There are no legal restrictions to share this data as long as they are properly anonymized.

Intention to publish date

30/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/06/2019: The following changes were made: 1. The recruitment end date was changed from 30/05/2019 to 30/09/2019. 2. The overall trial end date was changed from 30/09/2019 to 31/10/2019. 12/03/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 28/02/2019 to 30/05/2019 2. The overall end date was changed from 30/06/2019 to 30/09/2019 3. The intention to publish date was changed from 28/02/2020 to 30/09/2020 24/10/2018: The following changes have been made: 1. The recruitment end date has been changed from 15/09/2018 to 28/02/2019. 2. The overall trial end date has been changed from 15/11/2018 to 30/06/2019. 3. The intention to publish date has been changed from 30/06/2019 to 30/02/2020.