An interventional study of energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program and Usual Care in Metabolic Syndrome, Obesity Prevention and Obesity and Overweight, sponsored by IMDEA Food. Recruiting at 1 site in Spain. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by IMDEA Food · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the effect of a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity on weight loss in middle-aged adults (men and women 30-50 years old) with metabolic syndrome. The main questions it aims to answer are:
Is a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity able to promote weight loss maintenance in middle-aged men and women with metabolic syndrome? syndrome? Which are the sociodemographic barriers to adhere to a multifactorial lifestyle intervention to promote cardiometabolic health? How is the lifestyle pattern of middle-aged Spanish adults with metabolic
Researchers will compare a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity to a control intervention based on usual primary healthcare to see if the intervention improve cardiometabolic traits and promote weight loss maintenance after 1 year.
Participants in the intervention arm will be asked to follow an energy-reduced Mediterranean diet plus a physical activity program with the aim of reducing 5-10% of the initial weight in 6 months and of maintaining the weight lost after 1 year o follow-up.
Metabolic syndrome (MetS), characterized by the presence of hyperglycemia, hypertension, abdominal obesity and dyslipidemia, is associated with the development of non-communicable diseases such as cardiovascular disease, diabetes or different types of cancer. The prevalence of MetS is increasing in the population. Most of the affected population is elderly adult population (> 50 years), although the incidence of MetS in young adults is growing at a worrying rate. The presence of MetS is associated with chronic medication and has a great impact on the quality of life of individuals, but it also has a huge socioeconomic impact on the population. Therefore, implementing strategies aimed at preventing MetS at an early age is of crucial importance for maintaining population health.
Adopting healthier lifestyle habits has been shown to be a protective measure against MetS. Pursuing these changes to become part of people's daily routines takes time and they always face various obstacles along the way. There are 4 phases before achieving this change: one of mind reflection, another of preparation, one of action and finally maintenance.
The present study attempts, with middle-aged adult patients with MetS, to influence these 4 phases and evaluate whether changes in eating habits, more specifically, adherence to a Mediterranean diet with energy restriction, and physical activity, promoted within the frame of Primary Care have an impact on the reversal and control of such pathology: on the one hand, whether the general well- being of the participants is improved and how positive the changes are in the metabolic, anthropometric, analytical and cardiovascular health parameters and, on the other hand, the effect that occurs on nutrient intake and the overall dietary pattern. Moreover, without neglecting the maintenance phase that seeks to identify facilitators and impediments for its long-term maintenance outside the spectrum of action of the study.
The study will be an open, controlled, randomized clinical trial with parallel groups, made up of adults between 30 and 50 years of age with MetS, with one group in intervention for 6 months and one control group with recommendations from nursing clinics for populations with chronic diseases and/or analytical disorders. In month 12, 6 months after the completion of the intervention for each patient in the study, an evaluation of adherence to the therapeutic plan will be carried out of the group independently.
Data collection during the trial will be of 3 types: sociodemographic, anthropometric, dietary, clinical and analytical. Our hypothesis is that a change in diet and physical activity, promoted from the area of Primary Care in the young adult population with MetS, impacts the following aspects: encourage reflection on the need to change lifestyle habits; prepare the patient to make modifications aimed at improving their well-being; guide on the actions necessary to achieve the reversal and management of MetS and maintain life changes once the study is completed.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 106 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →IMDEA Food is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Smokers who have changed their smoking habit in the 6 months preceding the start of the study (including starting or stopping smoking).
- Participation in another trial that may interfere with this proposed study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The aim of this group is to serve as control comparator of the intervention. Participants allocated to this group will be asked to follow genera lifestyle recommendations included in the clinical guidelines for metabolic syndrome in primary healthcare settings
Behavioral: Usual Care
Participants in this group will be asked to follow an energy-reduced Mediterranean diet and a physical activity program with the aim of lossing 5-10% of the initial weight in 6 months
Behavioral: energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
An intensive multifactorial lifestyle intervention involving monthly individual and group sessions during 6 months. Participants will be asked to follow a Mediterranean diet with a 25% reduction in energy and a physical activity program based on WHO recommendations to achieve a moderate physical activity level.
Also known as: Multifactorial lifestyle intervention, energy-reduced mediterranean diet, Physical activity, Caloric restriction
Participants in the control group will be asked to follow general recommendations to adhere to a healthy lifestyle, as indicated in the clinical guidelines of general practitioners and nurses for adults with metabolic syndrome
Percentage of weight loss
Weight loss measured as % from baseline weight with a calibrated scale
Time frame: 6 months
Percentage of weight loss maintenance
Percentage of weight loss maintained after 1 year, measured by a calibrated scale
Time frame: 12 months
Change in waist perimeter (cm)
Waist circumference change (cm) after 6 months, measured at the midpoint between the last rib and the iliac crest using a flexible tap
Time frame: 6 months
Changes in tryglyceride level
Changes in trlyglycerides (mg/dL) after 6 months, measured from an overnight fasting blood with standard analyticial methods
Time frame: 6 months
Changes in fasting glucose levels
Changes in glucose levels (mg/dL), measured from blood collected after an overnight fast using standard analytical methods
Time frame: 6 months
Changes in glycated hemoglobin
Changes in % of glycated hemoglobin, measured from blood collected after and overnight fast, by standard methods
Time frame: 6 months
Plan to share: Yes — All IPD data that underlie results in a publication may be shared with other researcher only for non-profit scientific purposes upon reasonable request. The study protocol and the statistical analysis plan will be made public through an official publication. The results of this clinical study will be published folowing Open-Science Principles.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The protocol and the statistical analysis plan will be made publicly available at study recruitment ends. The IPD will be made accessible to other researcher 2 years after the publication of the main study outcomes
Access criteria: Anonymised, coded data (sociodemographic, anthropometric, clinical and biochemical) may be accessible to other researchers only for non-profit scientific purposes and upon reasonable request to the principal investigator.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 18 months is close to that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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