Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, Mediterranean diet, culinary medicine, lifestyle intervention, diet therapy, cardiovascular risk, insulin resistance, inflammation, oxidative stress, obesity
Brief summary
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
Interventions
Participants 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.
BEHAVIORALStandard nutritional counseling
Participants 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.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Men and women * Age between 30 and 60 years * Body mass index (BMI) between 20 and 35 kg/m² * Presence of metabolic syndrome defined as having at least three of the following criteria: 1. HDL cholesterol \<40 mg/dL in men and \<50 mg/dL in women 2. Fasting glucose \>100 mg/dL or use of hypoglycemic agents 3. Triglycerides ≥150 mg/dL or use of lipid-lowering medication 4. Blood pressure ≥130/85 mmHg 5. Waist circumference ≥102 cm in men and ≥88 cm in women
Exclusion criteria
* 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) * Moderate to severe psychiatric disorders that may compromise adherence to the intervention * History of cardiovascular events * BMI \>35 kg/m² * Extreme dietary patterns in the last 3 months (e.g., Atkins diet, very high-protein diets) * Excessive alcohol consumption (\>30 g/day for men and \>20 g/day for women) * Pregnancy or lactation * Previous culinary training or formal culinary education
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in metabolic syndrome components | Baseline, 3 months, and 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Body weight, fat mass and lean mass | Baseline, 3 months, and 6 months | 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 | Baseline, 3 months, and 6 months | Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA). |
| Height | Baseline, 3 months, and 6 months | Height, measured in centimeters (cm) using a wall-mounted stadiometer |
| Lipid profile | Baseline, 3 months, and 6 months | 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. |
| Liver enzymes | Baseline, 3 months, and 6 months | Liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and alkaline phosphatase (ALP), measured in units per liter (U/L) using standard laboratory methods. |
| Total and direct bilirubin | Baseline, 3 months, and 6 months | Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods. |
| Serum albumin and total protein | Baseline, 3 months, and 6 months | Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods. |
| Glycated hemoglobin | Baseline, 3 months, and 6 months | Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays. |
| Dietary intake | Baseline, 3 months, and 6 months | Dietary intake, assessed using a validated Food Frequency Questionnaire (FFQ) to estimate habitual energy and nutrient intake. Nutrient and energy intake are expressed in grams per day (g/day), milligrams per day (mg/day), micrograms per day (µg/day), or kilocalories per day (kcal/day), depending on the dietary component evaluated. |
| Mediterranean diet adherence | Baseline, 3 months, and 6 months | Mediterranean diet adherence, assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet. |
| Culinary habits | Baseline, 3 months, and 6 months | Culinary habits, assessed using the Home Cooking Frequency Questionnaire (HCFQ). The questionnaire evaluates the frequency of home cooking, food preparation behaviors, and culinary skills. Higher scores indicate greater frequency of home cooking and healthier culinary practices. |
Countries
Spain
Contacts
CONTACTVictoria S Pinto Manzo, Msc
PRINCIPAL_INVESTIGATORRosa M Casas Rodríguez, PhD
IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
Outcome results
None listed