Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07702695

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Barcelona, 08035, Spain

Location contact

Victoria S Pinto Manzo, Msc

CONTACT

[email protected]

+34 932275400 ext. 2907

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in metabolic syndrome components

    Time frame: 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.

Secondary outcomes

  1. Body weight, fat mass and lean mass

    Time frame: 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).

  2. Body fat

    Time frame: Baseline, 3 months, and 6 months

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

  3. Height

    Time frame: Baseline, 3 months, and 6 months

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

  4. Lipid profile

    Time frame: 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.

  5. Liver enzymes

    Time frame: 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.

  6. Total and direct bilirubin

    Time frame: Baseline, 3 months, and 6 months

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

  7. Serum albumin and total protein

    Time frame: Baseline, 3 months, and 6 months

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

  8. Glycated hemoglobin

    Time frame: Baseline, 3 months, and 6 months

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

  9. Dietary intake

    Time frame: 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.

  10. Mediterranean diet adherence

    Time frame: 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.

  11. Culinary habits

    Time frame: 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.

Other outcomes

  1. Reduced and oxidized glutathione

    Time frame: 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.

  2. Gut microbiota composition

    Time frame: 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 (%).

  3. Superoxide dismutase

    Time frame: Baseline, 3 months, and 6 months

    Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays.

  4. F2-isoprostanes

    Time frame: 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).

  5. Malondialdehyde

    Time frame: 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.

  6. Catalase

    Time frame: Baseline, 3 months, and 6 months

    Catalase (CAT), measured in units per liter (U/L) using standardized enzymatic assays.

  7. Inflammatory biomarkers

    Time frame: 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).

  8. Adipokines

    Time frame: 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).

  9. Adiponectin

    Time frame: Baseline, 3 months, and 6 months

    Adiponectin, measured in micrograms per milliliter (µg/mL) using enzyme-linked immunosorbent assay (ELISA).

  10. High-sensitivity C-reactive protein

    Time frame: 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.

  11. Circulating polyphenols and plasma carotenoids

    Time frame: 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.

  12. Urinary polyphenols

    Time frame: 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.

  13. Advanced glycation end products

    Time frame: Baseline, 3 months, and 6 months

    Advanced glycation end products (AGEs), measured in nanograms per milliliter (ng/mL) using enzyme-linked immunosorbent assay (ELISA).

  14. Fecal short-chain fatty acids

    Time frame: 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).

  15. Health-related quality of life

    Time frame: 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.

  16. Physical activity,

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria S Pinto Manzo, Msc

CONTACT

[email protected]

+34 932275400 ext. 2907

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: CUINAMET

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.