Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet
NCT ID: NCT01890070
Last Updated: 2015-12-10
Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2013-05-31
Brief Summary
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Detailed Description
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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:
* Anthropometric measures (body weight, height, waist, hip, abdominal, neck, arm and forearm circumferences).
* Skin fold measurements (bicipital, tricipital, subscapular, pectoral, supra iliac, abdominal, anterior thigh, internal thigh, supra patellar and popliteal);
* Blood Pressure;
* Body composition evaluation (bone, fat and lean mass), evaluated by DEXA (iDXA; GE
* Medical Systems, Milwaukee, WI) (Dual energy X-ray Absorptiometry; DPX Lunar Radiation Corp., Madison, Wisconsin, USA);
* Distribution of body fluids, evaluated by bioimpedensometry. Resistance, reactance, phase angle at 50 kHz will be measured using the Bioelectrical Impedance Analysis method (BIA 101S, by Akern/RIL System-Florence
* Analysis of genetic expression Participants will be randomized into groups.
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:
1. Standard Diet (SD) alone, and SD with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate);
2. High Fat diet (HF) alone, and HF with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
3. Low Carbohydrate diet (LC) alone, and LC with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
4. High Protein (HP) alone, and HP with functional food (40g of hazelnuts or 150 ml of biological red wine, or 100g of chestnuts, or 200g of wild mixed greens, or 100 g of olive oil, or 100 g of chocolate).
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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STANDARD DIET
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.
No Dietary Supplement
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)
STANDARD DIET WITH HAZELNUTS
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.
Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
STANDARD DIET WITH RED WINE
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.
Red wine
Italian Organic Red Wine
STANDARD DIET WITH CHESTNUTS
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.
Chestnut
Italian Organic Chestnut
STANDARD DIET WITH CHOCOLATE
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.
Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
STANDARD DIET WITH WILD MIXED GREEN
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.
Wild mixed greens
Italian organic wild mixed greens
STANDARD DIET WITH OLIVE OIL
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.
Olive Oil
Italian Organic Olive Oil
HIGH FAT DIET
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.
No Dietary Supplement
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)
HIGH FAT WITH HAZELNUTS
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.
Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
HIGH FAT WITH RED WINE
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.
Red wine
Italian Organic Red Wine
HIGH FAT WITH CHESTNUT
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.
Chestnut
Italian Organic Chestnut
HIGH FAT WITH CHOCOLATE
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.
Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
HIGH FAT WITH WILD MIXED GREEN
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.
Wild mixed greens
Italian organic wild mixed greens
HIGH FAT WITH OLIVE OIL
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.
Olive Oil
Italian Organic Olive Oil
LOW CARBOHYDRATE DIET
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.
No Dietary Supplement
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)
LOW CARBOHYDRATE DIET WITH HAZELNUT
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.
Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
LOW CARBOHYDRATE DIET WITH RED WINE
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.
Red wine
Italian Organic Red Wine
LOW CARBOHYDRATE DIET WITH CHESTNUT
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.
Chestnut
Italian Organic Chestnut
LOW CARBOHYDRATE DIET CHOCOLATE
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.
Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN
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.
Wild mixed greens
Italian organic wild mixed greens
LOW CARBOHYDRATE DIET WITH OLIVE OIL
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.
Olive Oil
Italian Organic Olive Oil
HIGH PROTEIN DIET
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.
No Dietary Supplement
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)
HIGH PROTEIN DIET WITH HAZELNUT
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
Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
HIGH PROTEIN DIET WITH RED WINE
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.
Red wine
Italian Organic Red Wine
HIGH PROTEIN DIET WITH CHESTNUT
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.
Chestnut
Italian Organic Chestnut
HIGH PROTEIN DIET WITH CHOCOLATE
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.
Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN
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.
Wild mixed greens
Italian organic wild mixed greens
HIGH PROTEIN DIET WITH OLIVE OIL
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.
Olive Oil
Italian Organic Olive Oil
Interventions
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Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Red wine
Italian Organic Red Wine
Olive Oil
Italian Organic Olive Oil
Wild mixed greens
Italian organic wild mixed greens
Chestnut
Italian Organic Chestnut
No Dietary Supplement
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
* Peripheral or cerebral vasculopathy
* Hepatic disease
* Diabetes Mellitus
* Autoimmune disease
* HIV/AIDS
* Neoplastic disease
* Use of the following medications: lipid-lowering medications, oral anti-diabetic medication or insulin, nitroglycerin, corticosteroids.
18 Years
75 Years
ALL
Yes
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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LAURA DI RENZO
Professor of Human Nutrition
Locations
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Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata
Rome, Rome, Italy
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DM 06/12/2011 n° prot. 32064
Identifier Type: -
Identifier Source: org_study_id