Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

13. července 2026 aktualizováno: 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

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Kontrolní skupina

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.

Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in metabolic syndrome components
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Body weight, fat mass and lean mass
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, 3 months, and 6 months
Height, measured in centimeters (cm) using a wall-mounted stadiometer
Baseline, 3 months, and 6 months
Lipid profile
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reduced and oxidized glutathione
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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,
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. března 2027

Dokončení studie (Odhadovaný)

1. března 2028

Termíny zápisu do studia

První předloženo

6. července 2026

První předloženo, které splnilo kritéria kontroly kvality

13. července 2026

První zveřejněno (Aktuální)

14. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit