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Metabolic SyndromeCUINAMETNCT07702695

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

A study testing Mediterranean diet-based culinary intervention and Standard nutritional counseling in people with Metabolic Syndrome, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Mediterranean diet-based culinary intervention and Standard nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
Sep 2026to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Victoria S Pinto Manzo, Msc contact

+34 932275400 ext. 2907

victoriasabinap@ub.edu

Spain1 site
  • IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona)

    Barcelona, Barcelona, 08035

    Victoria S Pinto Manzo, Msc, +34 932275400 ext. 2907, victoriasabinap@ub.edu

Other trials in Spain

About this study

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

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

Being tested
Mediterranean diet-based culinary intervention, Standard nutritional counseling
Keywords
metabolic syndrome, Mediterranean diet, culinary medicine, lifestyle intervention, diet therapy, cardiovascular risk, insulin resistance, inflammation, oxidative stress, obesity
Medical subject headings
Metabolic Syndrome, Insulin Resistance, Inflammation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean diet-based culinary interventionBehavioural

    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.

  • Standard nutritional counselingBehavioural

    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.

Study groups in NCT07702695
Study groupRoleWhat they receive
Culinary-Nutritional Intervention GroupExperimentalNot described
Receives: Behavioral: Mediterranean diet-based culinary intervention
Control groupActive comparatorNot described
Receives: Behavioral: Standard nutritional counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (11)
  1. Body weight, fat mass and lean mass

    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).

    Measured: Baseline, 3 months, and 6 months

  2. Body fat

    Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline, 3 months, and 6 months

  3. Height

    Height, measured in centimeters (cm) using a wall-mounted stadiometer

    Measured: Baseline, 3 months, and 6 months

  4. Lipid profile

    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.

    Measured: Baseline, 3 months, and 6 months

  5. Liver enzymes

    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.

    Measured: Baseline, 3 months, and 6 months

  6. Total and direct bilirubin

    Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods.

    Measured: Baseline, 3 months, and 6 months

  7. Serum albumin and total protein

    Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods.

    Measured: Baseline, 3 months, and 6 months

  8. Glycated hemoglobin

    Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays.

    Measured: Baseline, 3 months, and 6 months

  9. Dietary intake

    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.

    Measured: Baseline, 3 months, and 6 months

  10. Mediterranean diet adherence

    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.

    Measured: Baseline, 3 months, and 6 months

  11. Culinary habits

    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.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07702695
Sponsor's protocol ID
HCB/2026/0570
Acronym
CUINAMET
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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/nu13124492.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33562357
  • 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.

    PubMed 31694143
  • 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.

    PubMed 41599849
  • 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.

    PubMed 28611054
  • 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.

    PubMed 39059927
  • 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.

    PubMed 28847422
  • 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.

    PubMed 22166184
  • 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.

    PubMed 25316904

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean diet-based culinary intervention and Standard nutritional counseling in people with Metabolic Syndrome, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Victoria S Pinto Manzo, Msc (+34 932275400 ext. 2907, victoriasabinap@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in metabolic syndrome components (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07702695, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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