What is this study trying to find out about metabolic syndrome?

This study is examining whether a lifestyle program combining a Mediterranean diet with fewer calories and physical activity helps middle-aged adults with metabolic syndrome lose weight and keep it off. It also looks at the social factors that affect making these healthy changes. The study is sponsored by IMDEA Food and focuses on improving health through nutrition and exercise.

Who may be eligible for this metabolic syndrome clinical trial?

Adults between 30 and 50 years old with metabolic syndrome and a body mass index between 27 and 40 kg/m2 may qualify. Both men and women can participate, but pregnant or breastfeeding women and those with serious psychiatric illness or certain medical conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this metabolic syndrome clinical trial?

Study-related care, including the study diet program and all trial visits, is provided at no cost. However, personal travel and other related expenses may vary and are not guaranteed to be covered by the study.

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

Research Sites

52 weeks

Total Duration

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

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

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

Research Team

Lidia Daimiel Ruiz, Senior Researcher

Laura Villanova, Predoctoral researcher

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