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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IMDEA Nutrition

Madrid, Madrid, Spain, 28049