Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet

NCT01890070 | Unknown

• 1 other identifier: DM 06/12/2011 n° prot. 32064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

mediterranean diet, nutrigenomics, body composition, inflammation, oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Cardiovascular Risk Index

  Variation in cardiovascular risk index from baseline to 4 weeks

• Homeostatic Model Assessment (HOMA-IR)

  Variation in HOMA from baseline to 4 weeks

• Prognostic Inflammatory and Nutritional Index (PINI)

  Variation in PINI from baseline to 4 weeks

• Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB)

  Variation in expression of NFkappaB from baseline to 4 weeks

Study Arms (28)

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.

Other: No Dietary Supplement

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.

Dietary Supplement: Hazelnuts

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.

Dietary Supplement: Red wine

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.

Dietary Supplement: Chestnut

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.

Dietary Supplement: Chocolate

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.

Dietary Supplement: Wild mixed greens

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.

Dietary Supplement: Olive Oil

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.

Other: No Dietary Supplement

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.

Dietary Supplement: Hazelnuts

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.

Dietary Supplement: Red wine

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.

Dietary Supplement: Chestnut

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.

Dietary Supplement: Chocolate

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.

Dietary Supplement: Wild mixed greens

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.

Dietary Supplement: Olive Oil

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.

Other: No Dietary Supplement

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.

Dietary Supplement: Hazelnuts

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.

Dietary Supplement: Red wine

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.

Dietary Supplement: Chestnut

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.

Dietary Supplement: Chocolate

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.

Dietary Supplement: Wild mixed greens

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.

Dietary Supplement: Olive Oil

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.

Other: No Dietary Supplement

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

Dietary Supplement: Hazelnuts

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.

Dietary Supplement: Red wine

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.

Dietary Supplement: Chestnut

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.

Dietary Supplement: Chocolate

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.

Dietary Supplement: Wild mixed greens

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.

Dietary Supplement: Olive Oil

Interventions

Hazelnuts DIETARY_SUPPLEMENT

Italian hazelnuts from Piedmont with Protected Geographical Indication Certification

Also known as: Corylus avellana

HIGH FAT WITH HAZELNUTS; HIGH PROTEIN DIET WITH HAZELNUT; LOW CARBOHYDRATE DIET WITH HAZELNUT; STANDARD DIET WITH HAZELNUTS

Chocolate DIETARY_SUPPLEMENT

Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)

Also known as: Theobroma cacao

HIGH FAT WITH CHOCOLATE; HIGH PROTEIN DIET WITH CHOCOLATE; LOW CARBOHYDRATE DIET CHOCOLATE; STANDARD DIET WITH CHOCOLATE

Red wine DIETARY_SUPPLEMENT

Italian Organic Red Wine

Also known as: Vitis vinifera

HIGH FAT WITH RED WINE; HIGH PROTEIN DIET WITH RED WINE; LOW CARBOHYDRATE DIET WITH RED WINE; STANDARD DIET WITH RED WINE

Olive Oil DIETARY_SUPPLEMENT

Italian Organic Olive Oil

Also known as: Olea europea

HIGH FAT WITH OLIVE OIL; HIGH PROTEIN DIET WITH OLIVE OIL; LOW CARBOHYDRATE DIET WITH OLIVE OIL; STANDARD DIET WITH OLIVE OIL

Wild mixed greens DIETARY_SUPPLEMENT

Italian organic wild mixed greens

Also known as: Chicory, rocket, nettle

HIGH FAT WITH WILD MIXED GREEN; HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN; LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN; STANDARD DIET WITH WILD MIXED GREEN

Chestnut DIETARY_SUPPLEMENT

Italian Organic Chestnut

Also known as: Castanea sativa

HIGH FAT WITH CHESTNUT; HIGH PROTEIN DIET WITH CHESTNUT; LOW CARBOHYDRATE DIET WITH CHESTNUT; STANDARD DIET WITH CHESTNUTS

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)

HIGH FAT DIET; HIGH PROTEIN DIET; LOW CARBOHYDRATE DIET; STANDARD DIET

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years inclusive BMI \>19 kg/m2

You may not qualify if:

• Past history of ischaemic coronary artery disease
• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata

Rome, Rome, 00133, Italy

RECRUITING

Related Publications (15)

• 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.

  PMID: 41470854 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.

  PMID: 39339676 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.

  PMID: 36672947 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.

  PMID: 36203988 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.

  PMID: 31593559 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.

  PMID: 30419927 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.

  PMID: 29147070 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.

  PMID: 28855976 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.

  PMID: 28601084 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.

  PMID: 28537652 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.

  PMID: 28429343 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.

  PMID: 27709360 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.

  PMID: 26347355 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.

  PMID: 25432492 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.

  PMID: 24876915 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

Chocolate; whole grape extract; Olive Oil; horse chestnut seed

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils

Central Study Contacts

Laura Di Renzo, PhD

CONTACT

+39 0672596855; laura.di.renzo@uniroma2.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 1, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

IT (1)