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The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods conforming to the Mediterranean diet, in order to determine the effect functional foods have on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function, inflammation, nutritional status) and body composition in the context of four different diets (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of these nutraceutical foods in relation to different diets. Diets were chosen to reflect the standard reference diets used by the general population, so as the outcomes of the addition of each interventional food element may be interpreted in the context of a variety of dietary patterns.
This study envisages the enrollment of subjects, to be recruited consecutively from May 2013 to May 2015 from the staff of the laboratory of the Evaluation of Nutritional State, Nutrigenetics and nutrigenomics of the Human Nutrition and Diet section of the University of Rome Tor Vergata.
The study will be conducted in accordance with the Declaration of Helsinki, and approved by the Committee of the Ministero delle Politiche Alimentari e Forestali (MIPAAF) , Italy, approved by DM 06/12/2011 n° prot. 32064. All participants will be required to provide written informed consent for the study.
At the time of recruitment, relevant subject data will be collected including clinical history, dietary habits, pharmacological therapy, smoking habit, alcohol consumption and level of physical activity.
Exclusion criteria include history of coronary vascular disease, peripheral or cerebro- vascular disease, hepatic disease, diagnosis of diabetes mellitus, autoimmune disease, immunodeficiency syndrome or malignant neoplasia.
The subjects enrolled will undergo:
Each group will cycle through different interventions, according to a cross over study. The interventions are represented by different dietary plans based on different meals, consisting of:
The duration of the experimental period is 4 weeks for each diet, with a wash-out period of 3 weeks at the beginning of the study between one diet and the next.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARD DIET | Placebo Comparator | each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fiber) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| STANDARD DIET WITH HAZELNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification Three weeks of washout to avoid additive effects on treatments to follow. |
|
| STANDARD DIET WITH RED WINE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 ml of Italian organic Red Wine. Three weeks of washout to avoid additive effects on treatments to follow. |
|
| STANDARD DIET WITH CHESTNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Italian organic chestnuts. Three weeks of washout to avoid additive effects on treatments to follow. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hazelnuts | Dietary Supplement | Italian hazelnuts from Piedmont with Protected Geographical Indication Certification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sarcopenic index | To calculate the sarcopenic index three calculations will be made: Body Cell Mass Index from bioelectrical impedance analysis (body cell mass in kilograms divided by height in metres squared),and the Appendicular Skeletal Muscle Index (sum of appendicular muscle mass divided by height in metres squared)and Relative Skeletal Muscle Index (total body lean mass divided by height in metres squared)both calculated from dual-energy X-ray asorptiometry. | Variation in sarcopenic index from baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk Index | Cardiovascular Risk Index will be calculated from 3 formulas: Total Cholesterol (mg/dl) divided by High Density Lipoprotein (mg/dl), Low Density Lipoprotein (mg/dl) divided by High Density Lipoprotein (mg/dl), Log10 Triglycerides (mg/dl) divided by High Density Lipoprotein (mg/dl) | Variation in cardiovascular risk index from baseline to 4 weeks |
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Inclusion Criteria:Age:
18 to 75 years inclusive BMI >19 kg/m2
-
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Di Renzo, PhD | Contact | +39 0672596855 | laura.di.renzo@uniroma2.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata | Recruiting | Rome | Rome | 00133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41470854 | Derived | Di Renzo L, Frank G, Pala B, Cianci R, De Santis GL, Nicoletti F, Bigioni G, Ortoman M, Borro M, Simmaco M, Peluso D, De Lorenzo A, Gualtieri P. Characterization of Gut Microbiota Profile in Lipedema: A Pilot Study. Nutrients. 2025 Dec 13;17(24):3909. doi: 10.3390/nu17243909. | |
| 39339676 | Derived | Di Renzo L, Gualtieri P, Frank G, Cianci R, Raffaelli G, Peluso D, Bigioni G, De Lorenzo A. Sex-Specific Adherence to the Mediterranean Diet in Obese Individuals. Nutrients. 2024 Sep 12;16(18):3076. doi: 10.3390/nu16183076. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| C000722782 | whole grape extract |
| D000069463 | Olive Oil |
| C517354 | horse chestnut seed |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| STANDARD DIET WITH CHOCOLATE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| STANDARD DIET WITH WILD MIXED GREEN | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
|
| STANDARD DIET WITH OLIVE OIL | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient patient is required to consume per day : Standard diet (Mediterrean reference: carbohydrates 55%-60%; protein 15% - 20% of which 50% are of vegetable derivation; total fats < 30% e 30 g of fibers) with 100g of Italian organic Olive Oil Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT DIET | Placebo Comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH HAZELNUTS | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 40g of Italian hazelnuts from Piedmont with Protected Geographical Indication Certification. Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH RED WINE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%)with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH CHESTNUT | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Italian organic chestnuts. Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH CHOCOLATE | Experimental | Intervention type: each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH FAT WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High fat diet (carbohydrates 35%; protein 15%; total fats 50%) with 100 of Italian organic Olive oil Three weeks of washout to avoid additive effects on treatment following. |
|
| LOW CARBOHYDRATE DIET | Placebo Comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET WITH HAZELNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET WITH RED WINE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET WITH CHESTNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Italian organic chestnuts Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET CHOCOLATE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
|
| LOW CARBOHYDRATE DIET WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: Low carbohydrate diet (carbohydrates 35%; protein 30%; total fats 35%) with 100 of Italian organic Olive Oil Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET | Placebo Comparator | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET WITH HAZELNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 40g Italian hazelnuts from Piedmont with Protected Geographical Indication Certification |
|
| HIGH PROTEIN DIET WITH RED WINE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 ml of Italian organic Red Wine Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET WITH CHESTNUT | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Italian organic chestnuts Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET WITH CHOCOLATE | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 g of Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 200 g of Italian organic wild mixed green Three weeks of washout to avoid additive effects on treatments to follow. |
|
| HIGH PROTEIN DIET WITH OLIVE OIL | Experimental | Intervention type: Each patient is administered a food plan for four weeks. Every patient is required to consume per day: High protein diet (carbohydrates 30%; protein 40%; total fats 30%) with 100 of Italian organic Olive Oil This is followed by a 3 week wash out period, to neutralize any additive effects. |
|
|
| Chocolate | Dietary Supplement | Extra-dark Italian Chocolate (min. 70% of organic cocoa solids) |
|
|
| Red wine | Dietary Supplement | Italian Organic Red Wine |
|
|
| Olive Oil | Dietary Supplement | Italian Organic Olive Oil |
|
|
| Wild mixed greens | Dietary Supplement | Italian organic wild mixed greens |
|
|
| Chestnut | Dietary Supplement | Italian Organic Chestnut |
|
|
| No Dietary Supplement | Other | Mediterranean Reference Diet, High Fat Diet, Low Carbohydrate or High Protein Diet without an added dietary supplement (hazelnut, chocolate, red wine, wild mixed greens, chestnuts, olive oil) |
|
| Homeostatic Model Assessment (HOMA-IR) | HOMA will be calculated as follows: Blood glucose (mmol/L) x Blood Insulin (mU/L) divided by 22.5 | Variation in HOMA from baseline to 4 weeks |
| Prognostic Inflammatory and Nutritional Index (PINI) | PINI will be calculated as follows: [C-reactive Protein (mg/L) multiplied by alpha-1 acid glycoprotein (g/L)] divided by [albumin (g/L) multiplied by prealbumin (g/L)] | Variation in PINI from baseline to 4 weeks |
| Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB) | Measurement of gene up-regulation or down-regulation in order of magnitude set at ±2FC (fundamental-costant-based system of units) | Variation in expression of NFkappaB from baseline to 4 weeks |
| 36672947 | Derived | Gualtieri P, Marchetti M, Frank G, Smeriglio A, Trombetta D, Colica C, Cianci R, De Lorenzo A, Di Renzo L. Antioxidant-Enriched Diet on Oxidative Stress and Inflammation Gene Expression: A Randomized Controlled Trial. Genes (Basel). 2023 Jan 13;14(1):206. doi: 10.3390/genes14010206. |
| 36203988 | Derived | Marchetti M, Gualtieri P, De Lorenzo A, Trombetta D, Smeriglio A, Ingegneri M, Cianci R, Frank G, Schifano G, Bigioni G, Di Renzo L. Dietary omega-3 intake for the treatment of morning headache: A randomized controlled trial. Front Neurol. 2022 Sep 20;13:987958. doi: 10.3389/fneur.2022.987958. eCollection 2022. |
| 31593559 | Derived | Perrone MA, Gualtieri P, Gratteri S, Ali W, Sergi D, Muscoli S, Cammarano A, Bernardini S, Di Renzo L, Romeo F. Effects of postprandial hydroxytyrosol and derivates on oxidation of LDL, cardiometabolic state and gene expression: a nutrigenomic approach for cardiovascular prevention. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):419-426. doi: 10.2459/JCM.0000000000000816. |
| 30419927 | Derived | Di Renzo L, Cioccoloni G, Falco S, Abenavoli L, Moia A, Sinibaldi Salimei P, De Lorenzo A. Influence of FTO rs9939609 and Mediterranean diet on body composition and weight loss: a randomized clinical trial. J Transl Med. 2018 Nov 12;16(1):308. doi: 10.1186/s12967-018-1680-7. |
| 29147070 | Derived | Colica C, Avolio E, Bollero P, Costa de Miranda R, Ferraro S, Sinibaldi Salimei P, De Lorenzo A, Di Renzo L. Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety. Mediators Inflamm. 2017;2017:5650627. doi: 10.1155/2017/5650627. Epub 2017 Sep 24. |
| 28855976 | Derived | Colica C, Di Renzo L, Trombetta D, Smeriglio A, Bernardini S, Cioccoloni G, Costa de Miranda R, Gualtieri P, Sinibaldi Salimei P, De Lorenzo A. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial. Oxid Med Cell Longev. 2017;2017:2473495. doi: 10.1155/2017/2473495. Epub 2017 Aug 9. |
| 28601084 | Derived | De Lorenzo A, Costacurta M, Merra G, Gualtieri P, Cioccoloni G, Marchetti M, Varvaras D, Docimo R, Di Renzo L. Can psychobiotics intake modulate psychological profile and body composition of women affected by normal weight obese syndrome and obesity? A double blind randomized clinical trial. J Transl Med. 2017 Jun 10;15(1):135. doi: 10.1186/s12967-017-1236-2. |
| 28537652 | Derived | Colica C, Merra G, Gasbarrini A, De Lorenzo A, Cioccoloni G, Gualtieri P, Perrone MA, Bernardini S, Bernardo V, Di Renzo L, Marchetti M. Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2274-2289. |
| 28429343 | Derived | Di Renzo L, Merra G, Botta R, Gualtieri P, Manzo A, Perrone MA, Mazza M, Cascapera S, De Lorenzo A. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial. Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1610-1626. |
| 27709360 | Derived | De Lorenzo A, Bernardini S, Gualtieri P, Cabibbo A, Perrone MA, Giambini I, Di Renzo L. Mediterranean meal versus Western meal effects on postprandial ox-LDL, oxidative and inflammatory gene expression in healthy subjects: a randomized controlled trial for nutrigenomic approach in cardiometabolic risk. Acta Diabetol. 2017 Feb;54(2):141-149. doi: 10.1007/s00592-016-0917-2. Epub 2016 Oct 5. |
| 26347355 | Derived | Di Renzo L, Tyndall E, Gualtieri P, Carboni C, Valente R, Ciani AS, Tonini MG, De Lorenzo A. Association of body composition and eating behavior in the normal weight obese syndrome. Eat Weight Disord. 2016 Mar;21(1):99-106. doi: 10.1007/s40519-015-0215-y. Epub 2015 Sep 7. |
| 25432492 | Derived | Di Renzo L, Marsella LT, Sarlo F, Soldati L, Gratteri S, Abenavoli L, De Lorenzo A. C677T gene polymorphism of MTHFR and metabolic syndrome: response to dietary intervention. J Transl Med. 2014 Nov 29;12:329. doi: 10.1186/s12967-014-0329-4. |
| 24876915 | Derived | Di Renzo L, Carraro A, Valente R, Iacopino L, Colica C, De Lorenzo A. Intake of red wine in different meals modulates oxidized LDL level, oxidative and inflammatory gene expression in healthy people: a randomized crossover trial. Oxid Med Cell Longev. 2014;2014:681318. doi: 10.1155/2014/681318. Epub 2014 Apr 30. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D004042 |
| Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |