Status:
RECRUITING
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Lead Sponsor:
IMDEA Food
Conditions:
Metabolic Syndrome
Obesity Prevention
Eligibility:
All Genders
30-50 years
Phase:
NA
Brief 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 ...
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 car...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06857929
Start Date
March 1 2026
End Date
September 30 2028
Last Update
March 27 2026
Active Locations (1)
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1
IMDEA Nutrition
Madrid, Madrid, Spain, 28049