Condition category
Circulatory System
Date applied
28/05/2014
Date assigned
24/07/2014
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Predimed-plus is a study that will measure how successful an intensive weight-loss lifestyle programme involving an energy-restricted (calorie controlled) Mediterranean diet (Mediet) and a physical activity programme is compared to a less intensive program also involving a Mediterranean diet but no energy restrictions and no lifestyle or physical activity programmes. The aim is to see whether the more intensive programme is more likely to result in long-term weight-loss, a reduced risk of developing cardiovascular disease and a greater quality of life for older people with metabolic syndrome (the medical term for the combination of diabetes, high blood pressure and obesity) than when adopting the Mediterranean diet alone.

Who can participate?
Men aged 55 to 75 years and women aged 60-75 years with a body mass index (BMI) ≥27 to <40 kg/m2, no cardiovascular disease and with metabolic syndrome.

What does the study involve?
Participants are randomly allocated into one of two groups. The low-intensity intervention group are given a non-energy restricted Mediet. The intensive intervention group are given an energy-restricted Mediet, physical activity and lifestyle programmes and weight loss goals. Changes in body weight, quality of life or any instance of cardiovascular disease is recorded once a year.

What are the possible benefits and risks of participating?
Not provided at registration

Where is the study run from?
The Internal Medicine Department at the Hospital Clinic of Barcelona (Spain)

When is the study starting and how long is it expected to run for?
October 2013 to May 2020

Who is funding the study?
The European Research Council (Belgium) and the Carlos III Health Institute (Spain)

Who is the main contact?
Dr Ramon Estruch
restruch@clinic.ub.es

Trial website

http://www.predimedplus.com

Contact information

Type

Scientific

Primary contact

Dr Ramon Estruch

ORCID ID

Contact details

Internal Medicine Department Hospital Clinic of Barcelona. Villarroel
170 / Human Nutrition Unit
Universitat Rovira i Virgili. C/ Sant Llorenç 21/ Dpto
Medicina Preventiva y Salud Pública
Universidad de Navarra. Irunlarrea 1
Barcelona/ Reus (Tarragona) / Pamplona
08036 / 43201 / 31008
restruch@clinic.ub.es/ jordi.salas@urv.cat/ mamartinez@unav.es
Barcelona/ Reus (Tarragona) / Pamplona
08036
Spain
+34 93 2279365
restruch@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ERC 340918 & FIS PI13/00462

Study information

Scientific title

Cardiovascular effect of an intensive weight-loss lifestyle intervention based on an energy-restricted traditional Mediterranean diet (Mediet) together with behavioral intervention and physical activity in comparison with a less intensive program using Mediet, but without energy restriction or other lifestyle changes: a randomized field trial

Acronym

PREDIMED-PLUS

Study hypothesis

An intensive lifestyle intervention with an energy-restricted Mediet, increased physical activity, and behavioral therapy in comparison with Mediet alone, without other lifestyle changes, will reduce the risk of major cardiovascular outcomes (myocardial infarction, stroke, and cardiovascular mortality), be effective for weight loss and long-term weight-loss maintenance, and improve quality of life in older individuals with metabolic syndrome.

Ethics approval

Institutional Review Board of all participating centers.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular disease

Intervention

Participants are randomly assigned into two equal groups:
1. Low-intensity intervention with a 14-item Mediet (with supplemental extra-virgin olive oil and tree nuts given at no cost for the participant) without energy-restriction, without weight loss goals and without a physical activity program.
2. Intensive intervention with an energy-restricted Mediet (with supplemental extra-virgin olive oil and tree nuts given at no cost for the participant) together with increased physical activity, weight loss goals and behavioral intervention.

All participants will follow a 4-week run-in period to ensure compliance with the protocol. If compliant, they will be randomly allocated to one of the 2 interventions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
2. Changes of body weight.
3. Changes in quality of life.
All participants are evaluated yearly for primary and secondary endpoints.

Secondary outcome measures

Death of any cause and incidence of angina leading to a revascularization procedure, atrial fibrillation, peripheral artery disease, heart failure, diabetes mellitus and its complications, dementia, Parkinson disease, major unipolar depression, osteoporotic fractures, cholelithiasis or cholecystectomy, symptomatic gout or cancer (breast, prostate, lung, colorectal, or stomach).

Other intermediate outcomes are changes in:
1. Blood pressure
2. Fasting blood sugar
3. Serum lipid profile
4. Markers of inflammation
5. Other intermediate markers of cardiovascular risk
6. Overall diet and nutrient intake

All participants are evaluated yearly for primary and secondary endpoints.

Overall trial start date

01/10/2013

Overall trial end date

01/05/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants are community-dwelling high-risk people.
2. Men aged 55 to 75 years and women aged 60 to 75 years
3. Body mass index (BMI) between ≥ 27 y < 40 kg/m2
4. No cardiovascular disease (CVD) at enrolment
5. Who fulfil at least 3 of the criteria for the metabolic syndrome (Alberti et al., 2009). Diabetic participants will represent not more than 25% of the final sample.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

6000

Participant exclusion criteria

1. Unable or unwilling to give written informed consent or communicate with study staff.
2. Documented history of previous CVD, including angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or haemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (new york heart association class II or IV); hypertrophic cardiomyopathy; or history of aortic aneurism.
3. Active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer).
4. Impossibility to follow the recommended diet (for religious reasons, swallowing disorders, or other reasons).
5. A low predicted likelihood to change dietary habits according to the Prochaska and Diclemente stages of change model (Nigg et al., 1999).
6. Inability to follow the scheduled intervention visits (institutionalized individuals, lack of autonomy, unable to walk, lack of a stable address, travel plans, or other reason that render the subject unable to attend scheduled visits).
7. Body weight loss > 5 kg during the 6 months prior to the screening visit.
8. Intention to undergo bariatric surgery in the next 6 months.
9. History of very low-caloric diet during the 6 months prior to the screening visit.
10. Prior bariatric surgery or indication and willingness to receive a surgical procedure for weight loss in the near future.
11. History of inflammatory bowel disease or small bowel resection.
12. Obesity of known endocrine origin (with the exception of treated hypothyroidism).
13. Food allergy to any Mediet component.
14. Immunodeficiency or HIV-positive status.
15. Liver cirrhosis or chronic renal failure.
16. Psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression with hospitalization in past 6 months.
17. Any severe co-morbid condition with less than 24-month life expectancy.
18. Alcohol (total daily alcohol intake >50 g) or drug abuse within the past 6 months.
19. History of major organ transplantation.
20. Illiteracy.
21. Concurrent therapy with immunosuppressive drugs or cytotoxic agents.
22. Current treatment with systemic corticosteroids.
23. Current use of weight loss Medication.
24. Concurrent participation in another randomised clinical trial.
25. Patients with an acute infection or inflammation (i.e., pneumonia) are allowed to participate in the study 3 months after resolution of their condition.
26. Any other condition that may interfere with the completion of the study protocol.

Recruitment start date

01/10/2013

Recruitment end date

01/05/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Internal Medicine Department Hospital Clinic of Barcelona. Villarroel, 170 / Human Nutrition Unit, Universitat Rovira i Virgili. C/ Sant Llorenç 21/ Dpto, Medicina Preventiva y Salud Pública, Universidad de Navarra. Irunlarrea 1
Barcelona/ Reus (Tarragona) / Pamplona
08036
Spain

Sponsor information

Organisation

European Research Council (Belgium) / The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)

Sponsor details

Place Rogier 16
COV2 24/009 / C. Sinesio Delgado 4
Brussels / Madrid
Belgium / Spain
rtd-erc@ec.europa.eu / oficina.informacion@isciii.es
Brussels / Madrid
BE-1049 / ES 28
Belgium

Sponsor type

Other

Website

http://erc.europa.eu

Funders

Funder type

Other

Funder name

European Research Council Advanced Research Grant (Grant Agreement No.: 340918) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain); Ciberobn, Fis-Coordinated Grant PI13/00462, Rd 06/0045

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes