Actively Recruiting

Phase Not Applicable
Age: 30Years - 50Years
All Genders
ID06857929

Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk

Led by IMDEA Food · Updated on 2026-03-27

106

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

CONDITIONS

Brief Title

"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"

Who Can Participate

Age: 30Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 30 to 50 years
  • Body mass index (BMI) between 27 and 40 kg/m2
  • Diagnosed with metabolic syndrome according to established international criteria
  • Stable weight in the last 3 months with less than 4 kg change
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed illness interfering with intervention recommendations
  • Women who have undergone menopause
  • Pregnant or breastfeeding women
  • Serious psychiatric illness or disorder
  • Social, cultural, or psychological factors affecting adherence
  • Inability to communicate with study staff
  • Inability to follow the recommended diet or engage in physical activity
  • Low likelihood of modifying dietary habits based on behavior change stages
  • Difficulty attending scheduled appointments due to work, travel, or surgery
  • Therapeutic non-compliance
  • Participation in another professionally-led nutritional intervention
  • Medical treatment affecting weight, intake, or energy expenditure within 3 months before study
  • Recent changes in smoking habits within 6 months before study
  • Participation in another trial that may interfere with this study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 6 months

Participants in the intervention group follow an energy-reduced Mediterranean diet and a physical activity program aimed at losing 5-10% of their initial weight over 6 months. The control group follows general lifestyle recommendations for metabolic syndrome.

Monthly individual and group sessions for intervention group; control group follow-up visits as per clinical guidelines

Long-term Monitoring

Duration - 6 months

Participants are evaluated 6 months after completing the intervention to assess adherence to the therapeutic plan and maintenance of lifestyle changes.

1 follow-up visit at 12 months from baseline

Trial Site Locations

Total: 1 location

1

IMDEA Nutrition

Madrid, Madrid, Spain, 28049

Actively Recruiting

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Research Team

L

Lidia Daimiel Ruiz, Senior Researcher

L

Laura Villanova, Predoctoral researcher

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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