Metabolic SyndromeNUTRI-M-CareNCT06857929
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
A study testing energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program in people with Metabolic Syndrome and Obesity Prevention, run by IMDEA Food at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Metabolic Syndrome, Obesity Prevention, Obesity and Overweight
- What is being tested?
- energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 27-40 Kg/m2
- Metabolic syndrome according to International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity
- Stable weight in the last 3 months (weight changes < 4Kg)
- Be able to give informed consent
Who cannot join
- Have a diagnosed illness that interferes with the recommendations proposed in the intervention.
- Women with established menopause.
- Pregnant or breastfeeding women.
- Serious psychiatric illness/disorder.
- Social, cultural or psychological factors that may affect adherence to the intervention protocol.
- Inability to communicate with study staff.
Show all 14Show fewer
- Inability to follow recommended diet or inability to engage in physical activity.
- Low likelihood of modifying dietary habits according to the different stages of change according to the Prochaska and DiClemente model.
- Difficulty attending scheduled appointments within the intervention due to work schedule conflicts, travel plans, scheduled surgeries, among other reasons.
- Therapeutic non-compliance.
- Participating in a professionally-led nutritional intervention.
- Being under medical treatment that affects weight, intake or energy expenditure in the 3 months preceding the start of the study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lidia Daimiel Ruiz, Senior Researcher contact
Spain1 site, 1 recruiting
- Recruiting
IMDEA Nutrition
Madrid, Madrid, 28049
Lidia Daimiel Ruiz, PhD, 917278100, lidia.daimiel@nutrición.imdea.org
About this study
Official title: Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
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
Read more
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.
Read the detailed description
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.
- Being tested
- energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program, Usual Care
- Keywords
- metabolic syndrome, Mediterranean diet, Caloric restriction, Physical activity, Weight loss, Weight, body composition
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Motor Activity, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy reduced Mediterranean diet (25% caloric restriction) plus physical activity programBehavioural
Also called Multifactorial lifestyle intervention, energy-reduced mediterranean diet, Physical activity, Caloric restriction
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.
Usual CareBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | Active comparator | 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 Receives: Behavioral: Usual Care |
| Intervention Group (IG) | Experimental | 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 Receives: Behavioral: energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weight loss
Weight loss measured as % from baseline weight with a calibrated scale
Measured: 6 months
Percentage of weight loss maintenance
Percentage of weight loss maintained after 1 year, measured by a calibrated scale
Measured: 12 months
Secondary outcomes (4)
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
Measured: 6 months
Changes in tryglyceride level
Changes in trlyglycerides (mg/dL) after 6 months, measured from an overnight fasting blood with standard analyticial methods
Measured: 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
Measured: 6 months
Changes in glycated hemoglobin
Changes in % of glycated hemoglobin, measured from blood collected after and overnight fast, by standard methods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- It is a randomized, controlled, single blinded, parallel group clinical trial aiming to evaluate the effect of a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity on parameters of metabolic syndrome in middle-aged men and women.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMDEA Food
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidia Daimiel Ruiz, IMDEA Food
- Investigators
- Lidia Daimiel Ruiz, Senior Researcher, Principal investigator, IMDEA Food
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857929
- Sponsor's protocol ID
- IMD PI-071
- Acronym
- NUTRI-M-Care
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
- ClinicalTrials.gov ID
- NCT06857929
- Acronym / sponsor ID
- NUTRI-M-Care / IMD PI-071
- Keywords
- metabolic syndrome, Mediterranean diet, Caloric restriction, Physical activity, Weight loss, Weight, body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- IMDEA FoodUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 5 Mar 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a randomized, controlled, single blinded, parallel group clinical trial aiming to evaluate the effect of a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity on parameters of metabolic syndrome in middle-aged men and women.
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | Active comparator | Behavioral: Usual CareThe 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 |
| Intervention Group (IG) | Experimental | Behavioral: energy reduced Mediterranean diet (25% caloric restriction) plus physical activity programParticipants 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 27-40 Kg/m2
- Metabolic syndrome according to International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity
- Stable weight in the last 3 months (weight changes < 4Kg)
- Be able to give informed consent
Key exclusion criteria (14 listed)
- Have a diagnosed illness that interferes with the recommendations proposed in the intervention.
- Women with established menopause.
- Pregnant or breastfeeding women.
- Serious psychiatric illness/disorder.
- Social, cultural or psychological factors that may affect adherence to the intervention protocol.
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 |
|---|---|---|
| energy reduced Mediterranean diet (25% caloric restriction) plus physical activity programAlso: Multifactorial lifestyle intervention, energy-reduced mediterranean diet, Physical activity, Caloric restrictionAn 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. | Behavioural | Intervention Group (IG) |
| Usual CareParticipants 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 | Behavioural | Control group (CG) |
Primary outcome
Percentage of weight loss
Time frame: 6 months
Weight loss measured as % from baseline weight with a calibrated scale
Percentage of weight loss maintenance
Time frame: 12 months
Percentage of weight loss maintained after 1 year, measured by a calibrated scale
4 secondary outcomes
Change in waist perimeter (cm)
Time frame: 6 months
Changes in tryglyceride level
Time frame: 6 months
Changes in fasting glucose levels
Time frame: 6 months
Changes in glycated hemoglobin
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: 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.
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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.
Lidia Daimiel Ruiz, Senior Researcher contact
Lidia Daimiel Ruiz, Senior Researcher principal investigator
IMDEA Food
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program in people with Metabolic Syndrome and Obesity Prevention, run by IMDEA Food at 1 site in Spain.
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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidia Daimiel Ruiz, Senior Researcher (+34917278100 ext. 309, lidia.daimiel@alimentacion.imdea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of weight loss (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.