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

December 9, 2015 updated by: LAURA DI RENZO, University of Rome Tor Vergata

Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Recruiting
        • Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata
        • Principal Investigator:
          • Laura Di Renzo, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Olea europea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Variation in sarcopenic index from baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Variation in cardiovascular risk index from baseline to 4 weeks
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
Variation in HOMA from baseline to 4 weeks
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)]
Variation in PINI from baseline to 4 weeks
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)
Variation in expression of NFkappaB from baseline to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DM 06/12/2011 n° prot. 32064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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