A Mediterranean Diet-Based Culinary Intervention in Adults With Metabolic Syndrome (CUINAMET)
13. juli 2026 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Victoria S Pinto Manzo, Msc
- Telefonnummer: 2907 +34 932275400
- E-post: victoriasabinap@ub.edu
Studiesteder
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Barcelona
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Barcelona, Barcelona, Spania, 08035
- IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
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Ta kontakt med:
- Victoria S Pinto Manzo, Msc
- Telefonnummer: 2907 +34 932275400
- E-post: victoriasabinap@ub.edu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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:
- HDL cholesterol <40 mg/dL in men and <50 mg/dL in women
- Fasting glucose >100 mg/dL or use of hypoglycemic agents
- Triglycerides ≥150 mg/dL or use of lipid-lowering medication
- Blood pressure ≥130/85 mmHg
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Kontrollgruppe
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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. |
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Eksperimentell: Culinary-Nutritional Intervention Group
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Changes in metabolic syndrome components
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body weight, fat mass and lean mass
Tidsramme: Baseline, 3 months, and 6 months
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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).
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Baseline, 3 months, and 6 months
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Body fat
Tidsramme: Baseline, 3 months, and 6 months
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Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).
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Baseline, 3 months, and 6 months
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Height
Tidsramme: Baseline, 3 months, and 6 months
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Height, measured in centimeters (cm) using a wall-mounted stadiometer
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Baseline, 3 months, and 6 months
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Lipid profile
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Liver enzymes
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Total and direct bilirubin
Tidsramme: Baseline, 3 months, and 6 months
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Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods.
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Baseline, 3 months, and 6 months
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Serum albumin and total protein
Tidsramme: Baseline, 3 months, and 6 months
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Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods.
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Baseline, 3 months, and 6 months
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Glycated hemoglobin
Tidsramme: Baseline, 3 months, and 6 months
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Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays.
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Baseline, 3 months, and 6 months
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Dietary intake
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Mediterranean diet adherence
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Culinary habits
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reduced and oxidized glutathione
Tidsramme: Baseline, 3 months, and 6 months
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Reduced and oxidized glutathione (GSH and GSSG), measured in micromoles per liter (µmol/L) using enzymatic or chromatographic methods.
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Baseline, 3 months, and 6 months
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Gut microbiota composition
Tidsramme: Baseline, 3 months, and 6 months
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Gut microbiota composition, assessed by 16S ribosomal RNA (16S rRNA) gene sequencing of fecal DNA.
Relative abundance of bacterial taxa is expressed as percentage (%).
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Baseline, 3 months, and 6 months
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Superoxide dismutase
Tidsramme: Baseline, 3 months, and 6 months
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Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays.
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Baseline, 3 months, and 6 months
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F2-isoprostanes
Tidsramme: 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).
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Baseline, 3 months, and 6 months
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Malondialdehyde
Tidsramme: Baseline, 3 months, and 6 months
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Malondialdehyde (MDA), measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) or validated colorimetric assays.
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Baseline, 3 months, and 6 months
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Catalase
Tidsramme: Baseline, 3 months, and 6 months
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Catalase (CAT), measured in units per liter (U/L) using standardized enzymatic assays.
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Baseline, 3 months, and 6 months
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Inflammatory biomarkers
Tidsramme: Baseline, 3 months, and 6 months
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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).
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Baseline, 3 months, and 6 months
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Adipokines
Tidsramme: Baseline, 3 months, and 6 months
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Adipokines, including leptin and visfatin, measured in nanograms per milliliter (ng/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Adiponectin
Tidsramme: Baseline, 3 months, and 6 months
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Adiponectin, measured in micrograms per milliliter (µg/mL) using enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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High-sensitivity C-reactive protein
Tidsramme: 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.
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Baseline, 3 months, and 6 months
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Circulating polyphenols and plasma carotenoids
Tidsramme: 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.
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Baseline, 3 months, and 6 months
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Urinary polyphenols
Tidsramme: 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.
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Baseline, 3 months, and 6 months
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Advanced glycation end products
Tidsramme: Baseline, 3 months, and 6 months
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Advanced glycation end products (AGEs), measured in nanograms per milliliter (ng/mL) using enzyme-linked immunosorbent assay (ELISA).
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Baseline, 3 months, and 6 months
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Fecal short-chain fatty acids
Tidsramme: Baseline, 3 months, and 6 months
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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).
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Baseline, 3 months, and 6 months
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Health-related quality of life
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Physical activity,
Tidsramme: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Rosa M Casas Rodríguez, PhD, IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Babio N, Toledo E, Estruch R, Ros E, Martinez-Gonzalez MA, Castaner O, Bullo M, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Sorli JV, Salas-Salvado J; PREDIMED Study Investigators. Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial. CMAJ. 2014 Nov 18;186(17):E649-57. doi: 10.1503/cmaj.140764. Epub 2014 Oct 14.
- Bach-Faig A, Berry EM, Lairon D, Reguant J, Trichopoulou A, Dernini S, Medina FX, Battino M, Belahsen R, Miranda G, Serra-Majem L; Mediterranean Diet Foundation Expert Group. Mediterranean diet pyramid today. Science and cultural updates. Public Health Nutr. 2011 Dec;14(12A):2274-84. doi: 10.1017/S1368980011002515.
- La Puma J. What Is Culinary Medicine and What Does It Do? Popul Health Manag. 2016 Feb;19(1):1-3. doi: 10.1089/pop.2015.0003. Epub 2015 Jun 2. No abstract available.
- Wolfson JA, Leung CW, Richardson CR. More frequent cooking at home is associated with higher Healthy Eating Index-2015 score. Public Health Nutr. 2020 Sep;23(13):2384-2394. doi: 10.1017/S1368980019003549. Epub 2020 Jan 10.
- Godos J, Scazzina F, Paterno Castello C, Giampieri F, Quiles JL, Briones Urbano M, Battino M, Galvano F, Iacoviello L, de Gaetano G, Bonaccio M, Grosso G. Underrated aspects of a true Mediterranean diet: understanding traditional features for worldwide application of a "Planeterranean" diet. J Transl Med. 2024 Mar 21;22(1):294. doi: 10.1186/s12967-024-05095-w.
- Finkelstein A, Budd MA, Gray BE, Mirsky J, Tirosh A, Polak R. Personalized Culinary Medicine: Qualitative Analyses of Perceptions from Participants in Action and Contemplation Stages of Change Through a One-Year Bi-Center Randomized Controlled Trial. Nutrients. 2025 Feb 16;17(4):704. doi: 10.3390/nu17040704.
- Domper J, Gayoso L, Goni L, Perezabad L, Razquin C, de la O V, Etxeberria U, Ruiz-Canela M. An Intensive Culinary Intervention Programme to Promote Healthy Ageing: The SUKALMENA-InAge Feasibility Pilot Study. Nutrients. 2024 Jun 1;16(11):1735. doi: 10.3390/nu16111735.
- Sharma SV, McWhorter JW, Chow J, Danho MP, Weston SR, Chavez F, Moore LS, Almohamad M, Gonzalez J, Liew E, LaRue DM, Galvan E, Hoelscher DM, Tseng KC. Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Nutrients. 2021 Dec 15;13(12):4492. doi: 10.3390/nu13124492.
- Heredia NI, Macias-Navarro L, Guevara DC, Sharma SV, Chow J, Bentley SS, Chukuigwe O, Pappa A, McWhorter JW. Testing of a Culinary Medicine Intervention for Racially/Ethnically Diverse Adults With Type 2 Diabetes. J Nutr Educ Behav. 2025 Apr;57(4):263-273. doi: 10.1016/j.jneb.2024.11.006. Epub 2025 Jan 15.
- Glanz K, Metcalfe JJ, Folta SC, Brown A, Fiese B. Diet and Health Benefits Associated with In-Home Eating and Sharing Meals at Home: A Systematic Review. Int J Environ Res Public Health. 2021 Feb 7;18(4):1577. doi: 10.3390/ijerph18041577.
- Partearroyo T, Samaniego-Vaesken ML, Ruiz E, Aranceta-Bartrina J, Gil A, Gonzalez-Gross M, Ortega RM, Serra-Majem L, Varela-Moreiras G. Current Food Consumption amongst the Spanish ANIBES Study Population. Nutrients. 2019 Nov 5;11(11):2663. doi: 10.3390/nu11112663.
- Casucci MG, Munoz-Martinez J, Caneda-Ferron B, Salinas-Roca B, Orta-Ramirez A, Vidal E, Rodriguez-Monforte M, Medeiro da Costa I, Costa V, Renzi S, Carrillo-Alvarez E. The Association Between Mediterranean Diet -Related Health Literacy, Cooking Skills and Mediterranean Diet Adherence in the Spanish Population. Nutrients. 2026 Jan 12;18(2):235. doi: 10.3390/nu18020235.
- Liu G, Zong G, Hu FB, Willett WC, Eisenberg DM, Sun Q. Cooking Methods for Red Meats and Risk of Type 2 Diabetes: A Prospective Study of U.S. Women. Diabetes Care. 2017 Aug;40(8):1041-1049. doi: 10.2337/dc17-0204. Epub 2017 Jun 13.
- Vignesh A, Amal TC, Vasanth K. Food contaminants: Impact of food processing, challenges and mitigation strategies for food security. Food Res Int. 2024 Sep;191:114739. doi: 10.1016/j.foodres.2024.114739. Epub 2024 Jul 6.
- Rinaldi de Alvarenga JF, Tran C, Hurtado-Barroso S, Martinez-Huelamo M, Illan M, Lamuela-Raventos RM. Home cooking and ingredient synergism improve lycopene isomer production in Sofrito. Food Res Int. 2017 Sep;99(Pt 2):851-861. doi: 10.1016/j.foodres.2017.01.009. Epub 2017 Jan 11.
- Martinez-Larrad MT, Corbaton-Anchuelo A, Fernandez-Perez C, Lazcano-Redondo Y, Escobar-Jimenez F, Serrano-Rios M. Metabolic syndrome, glucose tolerance categories and the cardiovascular risk in Spanish population. Diabetes Res Clin Pract. 2016 Apr;114:23-31. doi: 10.1016/j.diabres.2016.02.003. Epub 2016 Feb 21.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mars 2028
Datoer for studieregistrering
Først innsendt
6. juli 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Ernæringsforstyrrelser
- Metabolske sykdommer
- Overernæring
- Kroppsvekt
- Glukosemetabolismeforstyrrelser
- Hyperinsulinisme
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Metabolsk syndrom
- Betennelse
- Insulinresistens
Andre studie-ID-numre
- HCB/2026/0570
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .