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

Official title

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

Overview

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

Interventions

• Behavioral Mediterranean diet-based culinary intervention
  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 ad
• Behavioral Standard nutritional counseling
  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

Primary outcome measures

• Changes in metabolic syndrome components [Time frame: Baseline, 3 months, and 6 months]

Secondary outcome measures (11)

• Body weight, fat mass and lean mass [Time frame: Baseline, 3 months, and 6 months]
• Body fat [Time frame: Baseline, 3 months, and 6 months]
• Height [Time frame: Baseline, 3 months, and 6 months]
• Lipid profile [Time frame: Baseline, 3 months, and 6 months]
• Liver enzymes [Time frame: Baseline, 3 months, and 6 months]
• Total and direct bilirubin [Time frame: Baseline, 3 months, and 6 months]
• Serum albumin and total protein [Time frame: Baseline, 3 months, and 6 months]
• Glycated hemoglobin [Time frame: Baseline, 3 months, and 6 months]
• Dietary intake [Time frame: Baseline, 3 months, and 6 months]
• Mediterranean diet adherence [Time frame: Baseline, 3 months, and 6 months]
• Culinary habits [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

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

Publications

• 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. PMID 38515140
• 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. PMID 40005034
• 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. PMID 38892668
• 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/nu13 PMID 34960044
• 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. PMID 39818659
• 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. PMID 26035069
• 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. PMID 31918785
• 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. PMID 33562357

Identifiers

NCT: NCT07702695 · HCB/2026/0570

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗