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A Mediterranean Diet-Based Culinary Intervention in Adults With Metabolic Syndrome (CUINAMET)

13 de julio de 2026 actualizado por: Rosa Casas, Fundacion Clinic per a la Recerca Biomédica

Impact of a Mediterranean Diet-based Culinary Medicine Intervention on the Reversal of Metabolic Syndrome and Biomarkers of Inflammation, Oxidative Stress, and Aging

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

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Victoria S Pinto Manzo, Msc
  • Número de teléfono: 2907 +34 932275400
  • Correo electrónico: victoriasabinap@ub.edu

Ubicaciones de estudio

    • Barcelona
      • Barcelona, Barcelona, España, 08035
        • IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
        • Contacto:
          • Victoria S Pinto Manzo, Msc
          • Número de teléfono: 2907 +34 932275400
          • Correo electrónico: victoriasabinap@ub.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Grupo de control

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.

Experimental: Culinary-Nutritional Intervention Group

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in metabolic syndrome components
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weight, fat mass and lean mass
Periodo de tiempo: 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).
Baseline, 3 months, and 6 months
Body fat
Periodo de tiempo: Baseline, 3 months, and 6 months
Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).
Baseline, 3 months, and 6 months
Height
Periodo de tiempo: Baseline, 3 months, and 6 months
Height, measured in centimeters (cm) using a wall-mounted stadiometer
Baseline, 3 months, and 6 months
Lipid profile
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months
Liver enzymes
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months
Total and direct bilirubin
Periodo de tiempo: Baseline, 3 months, and 6 months
Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods.
Baseline, 3 months, and 6 months
Serum albumin and total protein
Periodo de tiempo: Baseline, 3 months, and 6 months
Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods.
Baseline, 3 months, and 6 months
Glycated hemoglobin
Periodo de tiempo: Baseline, 3 months, and 6 months
Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays.
Baseline, 3 months, and 6 months
Dietary intake
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months
Mediterranean diet adherence
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months
Culinary habits
Periodo de tiempo: 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.
Baseline, 3 months, and 6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduced and oxidized glutathione
Periodo de tiempo: Baseline, 3 months, and 6 months
Reduced and oxidized glutathione (GSH and GSSG), measured in micromoles per liter (µmol/L) using enzymatic or chromatographic methods.
Baseline, 3 months, and 6 months
Gut microbiota composition
Periodo de tiempo: Baseline, 3 months, and 6 months
Gut microbiota composition, assessed by 16S ribosomal RNA (16S rRNA) gene sequencing of fecal DNA. Relative abundance of bacterial taxa is expressed as percentage (%).
Baseline, 3 months, and 6 months
Superoxide dismutase
Periodo de tiempo: Baseline, 3 months, and 6 months
Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays.
Baseline, 3 months, and 6 months
F2-isoprostanes
Periodo de tiempo: Baseline, 3 months, and 6 months
F2-isoprostanes, measured in picograms per milliliter (pg/mL) using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or enzyme-linked immunosorbent assay (ELISA).
Baseline, 3 months, and 6 months
Malondialdehyde
Periodo de tiempo: Baseline, 3 months, and 6 months
Malondialdehyde (MDA), measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) or validated colorimetric assays.
Baseline, 3 months, and 6 months
Catalase
Periodo de tiempo: Baseline, 3 months, and 6 months
Catalase (CAT), measured in units per liter (U/L) using standardized enzymatic assays.
Baseline, 3 months, and 6 months
Inflammatory biomarkers
Periodo de tiempo: Baseline, 3 months, and 6 months
Inflammatory biomarkers, including tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), monocyte chemoattractant protein-1 (MCP-1), and ghrelin, measured in picograms per milliliter (pg/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA).
Baseline, 3 months, and 6 months
Adipokines
Periodo de tiempo: Baseline, 3 months, and 6 months
Adipokines, including leptin and visfatin, measured in nanograms per milliliter (ng/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA).
Baseline, 3 months, and 6 months
Adiponectin
Periodo de tiempo: Baseline, 3 months, and 6 months
Adiponectin, measured in micrograms per milliliter (µg/mL) using enzyme-linked immunosorbent assay (ELISA).
Baseline, 3 months, and 6 months
High-sensitivity C-reactive protein
Periodo de tiempo: Baseline, 3 months, and 6 months
High-sensitivity C-reactive protein (hs-CRP), measured in milligrams per liter (mg/L) using immunoturbidimetric or immunoassay methods.
Baseline, 3 months, and 6 months
Circulating polyphenols and plasma carotenoids
Periodo de tiempo: Baseline, 3 months, and 6 months
Circulating polyphenols and plasma carotenoids, measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) coupled with mass spectrometry.
Baseline, 3 months, and 6 months
Urinary polyphenols
Periodo de tiempo: Baseline, 3 months, and 6 months
Urinary polyphenols, measured in milligrams of gallic acid equivalents per gram of creatinine (mg GAE/g creatinine) using the Folin-Ciocalteu method or chromatographic techniques.
Baseline, 3 months, and 6 months
Advanced glycation end products
Periodo de tiempo: Baseline, 3 months, and 6 months
Advanced glycation end products (AGEs), measured in nanograms per milliliter (ng/mL) using enzyme-linked immunosorbent assay (ELISA).
Baseline, 3 months, and 6 months
Fecal short-chain fatty acids
Periodo de tiempo: Baseline, 3 months, and 6 months
Fecal short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate, measured in micromoles per gram of feces (µmol/g) using gas chromatography with flame ionization detection (GC-FID).
Baseline, 3 months, and 6 months
Health-related quality of life
Periodo de tiempo: Baseline, 3 months, and 6 months
Health-related quality of life, assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100 for each of the eight domains and the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, with higher scores indicating better health-related quality of life.
Baseline, 3 months, and 6 months
Physical activity,
Periodo de tiempo: Baseline, 3 months, and 6 months
Physical activity, assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Physical activity is expressed as metabolic equivalent of task (MET)-minutes per week (MET-min/week), with higher values indicating greater levels of physical activity.
Baseline, 3 months, and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Rosa M Casas Rodríguez, PhD, IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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