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

NCT07702695 | Not Yet Recruiting

• 1 other identifier: HCB/2026/0570
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; Mediterranean diet; culinary medicine; lifestyle intervention; diet therapy; cardiovascular risk; insulin resistance; inflammation; oxidative stress; obesity

Outcome Measures

Primary Outcomes (1)

• Changes in metabolic syndrome components

  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

Secondary Outcomes (11)

• Body weight, fat mass and lean mass

  Baseline, 3 months, and 6 months

• Body fat

  Baseline, 3 months, and 6 months

• Height

  Baseline, 3 months, and 6 months

• Lipid profile

  Baseline, 3 months, and 6 months

• Liver enzymes

  Baseline, 3 months, and 6 months

Other Outcomes (16)

• Reduced and oxidized glutathione

  Baseline, 3 months, and 6 months

• Gut microbiota composition

  Baseline, 3 months, and 6 months

• Superoxide dismutase

  Baseline, 3 months, and 6 months

Study Arms (2)

Culinary-Nutritional Intervention Group

EXPERIMENTAL

Behavioral: Mediterranean diet-based culinary intervention

Control group

ACTIVE COMPARATOR

Behavioral: Standard nutritional counseling

Interventions

Mediterranean diet-based culinary intervention BEHAVIORAL

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.

Culinary-Nutritional Intervention Group

Standard nutritional counseling BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (16)

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  PMID: 38515140 BACKGROUND

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  PMID: 34960044 BACKGROUND

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  PMID: 33562357 BACKGROUND

• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Inflammation; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Rosa M Casas Rodríguez, PhD

  IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria S Pinto Manzo, Msc

CONTACT

+34 932275400; victoriasabinap@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Cardiovascular Risk, Nutrition and Aging Laboratory, Cardiovascular Risk Group

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)