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

Launched by IMDEA FOOD · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition," is designed to explore how a combined approach of following a Mediterranean diet, reducing calorie intake, and increasing physical activity can help middle-aged adults (ages 30-50) with metabolic syndrome lose weight and maintain that weight loss over time. The researchers want to find out if this multifactorial lifestyle change is effective in promoting better health and if there are specific challenges that might make it harder for people to stick with the program.

To be eligible for this trial, participants should have a body mass index (BMI) between 27 and 40 and meet the criteria for metabolic syndrome, which includes factors like high blood pressure and blood sugar levels. They must also have maintained a stable weight for the last three months. Participants will be asked to follow the Mediterranean diet and a physical activity program with the goal of losing 5-10% of their initial weight within six months and keeping it off for a year. The study is not yet recruiting participants, so there’s still time to learn more about it before getting involved.

Gender

ALL

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.