About this trial
Metabolic syndrome is a major public health concern associated with an increased risk of cardiovascular disease, type 2 diabetes, and premature mortality. The Mediterranean diet has consistently demonstrated beneficial effects on metabolic health and is recommended as a dietary strategy for the prevention and management of metabolic syndrome. However, most interventions have focused on conventional nutritional counseling and have paid limited attention to the culinary and gastronomic skills required to translate dietary recommendations into sustainable eating behaviors.
This randomized controlled trial will evaluate the effectiveness of a Mediterranean diet-based nutritional intervention complemented by culinary medicine training sessions compared with a nutritional intervention alone in Spanish adults with metabolic syndrome. The culinary medicine component is designed to enhance participants' food preparation skills, confidence in cooking, and ability to incorporate Mediterranean dietary principles into their daily lives.
Participants will be followed for 6 months to assess changes in metabolic syndrome components and other metabolic health indicators. The study aims to determine whether the integration of culinary medicine education enhances the effectiveness of conventional nutritional counseling in improving metabolic syndrome outcomes and promoting long-term adherence to a Mediterranean dietary pattern
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women
Age between 30 and 60 years
Body mass index (BMI) between 20 and 35 kg/m²
HDL cholesterol <40 mg/dL in men and <50 mg/dL in women
Disqualifiers
Food allergies or intolerances to foods typical of the Mediterranean diet
Gluten intolerance or celiac disease
Adherence to a vegetarian or vegan diet
Eating disorders (including anorexia nervosa, bulimia nervosa, and binge eating disorder)
Trial design
Parallel
Treatments tested in this trial
Mediterranean diet-based culinary intervention
BehavioralParticipants assigned to the culinary-nutritional intervention group will receive three individualized nutritional counseling sessions in Mediterranean diet, at baseline, 3 months, and 6 months, including health assessments and questionnaire administration at each visit. At the baseline visit, participants will receive a Mediterranean recipe booklet. Throughout the intervention, they will also receive educational videos featuring Mediterranean culinary preparations and cooking techniques. In addition, participants will attend nine hands-on culinary medicine workshops over the 6-month intervention period. Workshops will be conducted every two weeks during the first 3 months (six workshops) and monthly during the last 3 months (three workshops). The workshops will focus on Mediterranean diet principles, healthy cooking skills, meal planning, food selection, and preparation of Mediterranean-style recipes to facilitate adherence to the dietary intervention.
Standard nutritional counseling
BehavioralParticipants assigned to the control group will receive standard nutritional counseling in Mediterranean diet, consisting of three individual consultations at baseline, 3 months, and 6 months to monitor adherence to dietary recommendations. At each visit, health parameters will be assessed and questionnaires will be administered to evaluate dietary behavior and related outcomes. At baseline, 3 months, and 6 months, participants will undergo the same measurements as the intervention group. After completion of the study, participants in the control group will be provided with the Mediterranean recipe booklet and access to the educational videos on Mediterranean culinary preparations used in the intervention group.
Treatment groups
Trial outcomes
Primary outcomes
Changes in metabolic syndrome components
Changes in metabolic syndrome components according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria, including waist circumference, blood pressure, fasting glucose, triglycerides, and HDL cholesterol, measured as continuous variables, using a score ranging from 1 to 5.
Secondary outcomes
Body weight, fat mass and lean mass
Weight in kilograms (kg) using a calibrated electronic scale. Fat mass and lean mass in kilograms (kg) measured using dual-energy X-ray absorptiometry (DXA).
Body fat
Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).
Height
Height, measured in centimeters (cm) using a wall-mounted stadiometer
Lipid profile
Lipid profile including total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), triglycerides (mg/dl), VLDL cholesterol (mg/dl), and non-HDL cholesterol (mg/dl) measured using standard enzymatic methods.
Other outcomes
Reduced and oxidized glutathione
Reduced and oxidized glutathione (GSH and GSSG), measured in micromoles per liter (µmol/L) using enzymatic or chromatographic methods.
Gut microbiota composition
Gut microbiota composition, assessed by 16S ribosomal RNA (16S rRNA) gene sequencing of fecal DNA. Relative abundance of bacterial taxa is expressed as percentage (%).
Superoxide dismutase
Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays.
F2-isoprostanes
F2-isoprostanes, measured in picograms per milliliter (pg/mL) using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or enzyme-linked immunosorbent assay (ELISA).
Sponsors and contacts
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