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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culinary-Nutritional Intervention Group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 3 months, and 6 months |
| Body fat |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced and oxidized glutathione | Reduced and oxidized glutathione (GSH and GSSG), measured in micromoles per liter (µmol/L) using enzymatic or chromatographic methods. | Baseline, 3 months, and 6 months |
| Gut microbiota composition |
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria S Pinto Manzo, Msc | Contact | +34 932275400 | 2907 | victoriasabinap@ub.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rosa M Casas Rodríguez, PhD | IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer (Hospital Clínic de Barcelona) | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38515140 | Background | 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. | |
| 40005034 |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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. |
|
Body fat expressed as a percentage (%) measured using dual-energy X-ray absorptiometry (DXA).
| Baseline, 3 months, and 6 months |
| Height | Height, measured in centimeters (cm) using a wall-mounted stadiometer | Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months |
| Total and direct bilirubin | Total and direct bilirubin, measured in micromoles per liter (µmol/L) using standard laboratory methods. | Baseline, 3 months, and 6 months |
| Serum albumin and total protein | Serum albumin and total protein, measured in grams per liter (g/L) using standard laboratory methods. | Baseline, 3 months, and 6 months |
| Glycated hemoglobin | Glycated hemoglobin (HbA1c), measured as a percentage (%) using standardized laboratory assays. | Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months |
| 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. | Baseline, 3 months, and 6 months |
| 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. | 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 (%).
| Baseline, 3 months, and 6 months |
| Superoxide dismutase | Superoxide dismutase (SOD), measured in units per milliliter (U/mL) using standardized enzymatic assays. | Baseline, 3 months, and 6 months |
| F2-isoprostanes | F2-isoprostanes, measured in picograms per milliliter (pg/mL) using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or enzyme-linked immunosorbent assay (ELISA). | Baseline, 3 months, and 6 months |
| Malondialdehyde | Malondialdehyde (MDA), measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) or validated colorimetric assays. | Baseline, 3 months, and 6 months |
| Catalase | Catalase (CAT), measured in units per liter (U/L) using standardized enzymatic assays. | Baseline, 3 months, and 6 months |
| Inflammatory biomarkers | 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). | Baseline, 3 months, and 6 months |
| Adipokines | Adipokines, including leptin and visfatin, measured in nanograms per milliliter (ng/mL) using multiplex immunoassays or enzyme-linked immunosorbent assay (ELISA). | Baseline, 3 months, and 6 months |
| Adiponectin | Adiponectin, measured in micrograms per milliliter (µg/mL) using enzyme-linked immunosorbent assay (ELISA). | Baseline, 3 months, and 6 months |
| High-sensitivity C-reactive protein | High-sensitivity C-reactive protein (hs-CRP), measured in milligrams per liter (mg/L) using immunoturbidimetric or immunoassay methods. | Baseline, 3 months, and 6 months |
| Circulating polyphenols and plasma carotenoids | Circulating polyphenols and plasma carotenoids, measured in micromoles per liter (µmol/L) using high-performance liquid chromatography (HPLC) coupled with mass spectrometry. | Baseline, 3 months, and 6 months |
| Urinary polyphenols | 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. | Baseline, 3 months, and 6 months |
| Advanced glycation end products | Advanced glycation end products (AGEs), measured in nanograms per milliliter (ng/mL) using enzyme-linked immunosorbent assay (ELISA). | Baseline, 3 months, and 6 months |
| Fecal short-chain fatty acids | 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). | Baseline, 3 months, and 6 months |
| Health-related quality of life | 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. | Baseline, 3 months, and 6 months |
| Physical activity, | 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. | Baseline, 3 months, and 6 months |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |