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

U

University of Rome Tor Vergata

Status

Unknown

Conditions

Obesity

Treatments

Other: No Dietary Supplement
Dietary Supplement: Wild mixed greens
Dietary Supplement: Chestnut
Dietary Supplement: Olive Oil
Dietary Supplement: Chocolate
Dietary Supplement: Red wine
Dietary Supplement: Hazelnuts

Study type

Interventional

Funder types

Other

Identifiers

NCT01890070
DM 06/12/2011 n° prot. 32064

Details and patient eligibility

About

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.

Full 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: 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); 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). 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). 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

50 participants in 28 patient groups, including a placebo group

STANDARD DIET
Placebo Comparator group
Description:
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.
Treatment:
Other: No Dietary Supplement
STANDARD DIET WITH HAZELNUTS
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Hazelnuts
STANDARD DIET WITH RED WINE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Red wine
STANDARD DIET WITH CHESTNUTS
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chestnut
STANDARD DIET WITH CHOCOLATE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chocolate
STANDARD DIET WITH WILD MIXED GREEN
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Wild mixed greens
STANDARD DIET WITH OLIVE OIL
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Olive Oil
HIGH FAT DIET
Placebo Comparator group
Description:
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.
Treatment:
Other: No Dietary Supplement
HIGH FAT WITH HAZELNUTS
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Hazelnuts
HIGH FAT WITH RED WINE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Red wine
HIGH FAT WITH CHESTNUT
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chestnut
HIGH FAT WITH CHOCOLATE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chocolate
HIGH FAT WITH WILD MIXED GREEN
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Wild mixed greens
HIGH FAT WITH OLIVE OIL
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Olive Oil
LOW CARBOHYDRATE DIET
Placebo Comparator group
Description:
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.
Treatment:
Other: No Dietary Supplement
LOW CARBOHYDRATE DIET WITH HAZELNUT
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Hazelnuts
LOW CARBOHYDRATE DIET WITH RED WINE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Red wine
LOW CARBOHYDRATE DIET WITH CHESTNUT
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chestnut
LOW CARBOHYDRATE DIET CHOCOLATE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chocolate
LOW CARBOHYDRATE DIET WITH WILD MIXED GREEN
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Wild mixed greens
LOW CARBOHYDRATE DIET WITH OLIVE OIL
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Olive Oil
HIGH PROTEIN DIET
Placebo Comparator group
Description:
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.
Treatment:
Other: No Dietary Supplement
HIGH PROTEIN DIET WITH HAZELNUT
Experimental group
Description:
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
Treatment:
Dietary Supplement: Hazelnuts
HIGH PROTEIN DIET WITH RED WINE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Red wine
HIGH PROTEIN DIET WITH CHESTNUT
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chestnut
HIGH PROTEIN DIET WITH CHOCOLATE
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Chocolate
HIGH PROTEIN DIET WITH ITALIAN ORGANIC WILD MIXED GREEN
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Wild mixed greens
HIGH PROTEIN DIET WITH OLIVE OIL
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Olive Oil

Trial contacts and locations

1

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Central trial contact

Laura Di Renzo, PhD

Data sourced from clinicaltrials.gov

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