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

13 de julho de 2026 atualizado 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

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Estimado)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Barcelona
      • Barcelona, Barcelona, Espanha, 08035
        • IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Grupo de controle

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in metabolic syndrome components
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Body weight, fat mass and lean mass
Prazo: 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
Prazo: 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
Prazo: Baseline, 3 months, and 6 months
Height, measured in centimeters (cm) using a wall-mounted stadiometer
Baseline, 3 months, and 6 months
Lipid profile
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Reduced and oxidized glutathione
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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,
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

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NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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