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

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