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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01890070
Recruitment Status : Unknown
Verified December 2015 by LAURA DI RENZO, University of Rome Tor Vergata.
Recruitment status was:  Recruiting
First Posted : July 1, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
LAURA DI RENZO, University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Hazelnuts Dietary Supplement: Chocolate Dietary Supplement: Red wine Dietary Supplement: Olive Oil Dietary Supplement: Wild mixed greens Dietary Supplement: Chestnut Other: No Dietary Supplement Not Applicable

Detailed Description:

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:

  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study
Study Start Date : May 2013
Estimated Primary Completion Date : January 2016

Arm Intervention/treatment
Placebo Comparator: 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.

Other: 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)

Experimental: 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.

Dietary Supplement: Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Other Name: Corylus avellana

Experimental: 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.

Dietary Supplement: Red wine
Italian Organic Red Wine
Other Name: Vitis vinifera

Experimental: 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.

Dietary Supplement: Chestnut
Italian Organic Chestnut
Other Name: Castanea sativa

Experimental: 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.

Dietary Supplement: Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Other Name: Theobroma cacao

Experimental: 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.

Dietary Supplement: Wild mixed greens
Italian organic wild mixed greens
Other Name: Chicory, rocket, nettle

Experimental: 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.

Dietary Supplement: Olive Oil
Italian Organic Olive Oil
Other Name: Olea europea

Placebo Comparator: 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.

Other: 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)

Experimental: 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.

Dietary Supplement: Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Other Name: Corylus avellana

Experimental: 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.

Dietary Supplement: Red wine
Italian Organic Red Wine
Other Name: Vitis vinifera

Experimental: 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.

Dietary Supplement: Chestnut
Italian Organic Chestnut
Other Name: Castanea sativa

Experimental: 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.

Dietary Supplement: Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Other Name: Theobroma cacao

Experimental: 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.

Dietary Supplement: Wild mixed greens
Italian organic wild mixed greens
Other Name: Chicory, rocket, nettle

Experimental: 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.

Dietary Supplement: Olive Oil
Italian Organic Olive Oil
Other Name: Olea europea

Placebo Comparator: 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.

Other: 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)

Experimental: 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.

Dietary Supplement: Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Other Name: Corylus avellana

Experimental: 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.

Dietary Supplement: Red wine
Italian Organic Red Wine
Other Name: Vitis vinifera

Experimental: 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.

Dietary Supplement: Chestnut
Italian Organic Chestnut
Other Name: Castanea sativa

Experimental: 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.

Dietary Supplement: Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Other Name: Theobroma cacao

Experimental: 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.

Dietary Supplement: Wild mixed greens
Italian organic wild mixed greens
Other Name: Chicory, rocket, nettle

Experimental: 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.

Dietary Supplement: Olive Oil
Italian Organic Olive Oil
Other Name: Olea europea

Placebo Comparator: 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.

Other: 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)

Experimental: 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

Dietary Supplement: Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
Other Name: Corylus avellana

Experimental: 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.

Dietary Supplement: Red wine
Italian Organic Red Wine
Other Name: Vitis vinifera

Experimental: 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.

Dietary Supplement: Chestnut
Italian Organic Chestnut
Other Name: Castanea sativa

Experimental: 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.

Dietary Supplement: Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
Other Name: Theobroma cacao

Experimental: 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.

Dietary Supplement: Wild mixed greens
Italian organic wild mixed greens
Other Name: Chicory, rocket, nettle

Experimental: 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.

Dietary Supplement: Olive Oil
Italian Organic Olive Oil
Other Name: Olea europea




Primary Outcome Measures :
  1. Sarcopenic index [ Time Frame: Variation in sarcopenic index from baseline to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Cardiovascular Risk Index [ Time Frame: Variation in cardiovascular risk index from baseline to 4 weeks ]
    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)

  2. Homeostatic Model Assessment (HOMA-IR) [ Time Frame: Variation in HOMA from baseline to 4 weeks ]
    HOMA will be calculated as follows: Blood glucose (mmol/L) x Blood Insulin (mU/L) divided by 22.5

  3. Prognostic Inflammatory and Nutritional Index (PINI) [ Time Frame: Variation in PINI from baseline to 4 weeks ]
    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)]

  4. Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB) [ Time Frame: Variation in expression of NFkappaB from baseline to 4 weeks ]
    Measurement of gene up-regulation or down-regulation in order of magnitude set at ±2FC (fundamental-costant-based system of units)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Age:

18 to 75 years inclusive BMI >19 kg/m2

-

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890070


Contacts
Layout table for location contacts
Contact: Laura Di Renzo, PhD +39 0672596855 laura.di.renzo@uniroma2.it

Locations
Layout table for location information
Italy
Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata Recruiting
Rome, Italy, 00133
Principal Investigator: Laura Di Renzo, Phd         
Sponsors and Collaborators
University of Rome Tor Vergata

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: LAURA DI RENZO, Professor of Human Nutrition, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01890070    
Other Study ID Numbers: DM 06/12/2011 n° prot. 32064
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by LAURA DI RENZO, University of Rome Tor Vergata:
mediterranean diet, nutrigenomics, body composition, inflammation, oxidative stress