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

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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

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE July 1, 2013
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • 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)
  • 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
  • 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)]
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet
Official Title  ICMJE Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Hazelnuts
    Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
    Other Name: Corylus avellana
  • Dietary Supplement: Chocolate
    Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
    Other Name: Theobroma cacao
  • Dietary Supplement: Red wine
    Italian Organic Red Wine
    Other Name: Vitis vinifera
  • Dietary Supplement: Olive Oil
    Italian Organic Olive Oil
    Other Name: Olea europea
  • Dietary Supplement: Wild mixed greens
    Italian organic wild mixed greens
    Other Name: Chicory, rocket, nettle
  • Dietary Supplement: Chestnut
    Italian Organic Chestnut
    Other Name: Castanea sativa
  • 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)
Study Arms  ICMJE
  • 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.

    Intervention: Other: No Dietary Supplement
  • 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.

    Intervention: Dietary Supplement: Hazelnuts
  • 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.

    Intervention: Dietary Supplement: Red wine
  • 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.

    Intervention: Dietary Supplement: Chestnut
  • 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.

    Intervention: Dietary Supplement: Chocolate
  • 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.

    Intervention: Dietary Supplement: Wild mixed greens
  • 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.

    Intervention: Dietary Supplement: Olive Oil
  • 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.

    Intervention: Other: No Dietary Supplement
  • 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.

    Intervention: Dietary Supplement: Hazelnuts
  • 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.

    Intervention: Dietary Supplement: Red wine
  • 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.

    Intervention: Dietary Supplement: Chestnut
  • 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.

    Intervention: Dietary Supplement: Chocolate
  • 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.

    Intervention: Dietary Supplement: Wild mixed greens
  • 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.

    Intervention: Dietary Supplement: Olive Oil
  • 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.

    Intervention: Other: No Dietary Supplement
  • 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.

    Intervention: Dietary Supplement: Hazelnuts
  • 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.

    Intervention: Dietary Supplement: Red wine
  • 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.

    Intervention: Dietary Supplement: Chestnut
  • 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.

    Intervention: Dietary Supplement: Chocolate
  • 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.

    Intervention: Dietary Supplement: Wild mixed greens
  • 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.

    Intervention: Dietary Supplement: Olive Oil
  • 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.

    Intervention: Other: No Dietary Supplement
  • 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

    Intervention: Dietary Supplement: Hazelnuts
  • 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.

    Intervention: Dietary Supplement: Red wine
  • 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.

    Intervention: Dietary Supplement: Chestnut
  • 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.

    Intervention: Dietary Supplement: Chocolate
  • 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.

    Intervention: Dietary Supplement: Wild mixed greens
  • 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.

    Intervention: Dietary Supplement: Olive Oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01890070
Other Study ID Numbers  ICMJE DM 06/12/2011 n° prot. 32064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LAURA DI RENZO, University of Rome Tor Vergata
Study Sponsor  ICMJE University of Rome Tor Vergata
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rome Tor Vergata
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP