Clinical trial NCT01890070: Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet
Official title: Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet - A Cross Over Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: mediterranean diet, nutrigenomics, body composition, inflammation, oxidative stress
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: Inclusion Criteria:Age:

18 to 75 years inclusive BMI \>19 kg/m2

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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.

Primary outcomes:
measure: Sarcopenic index
timeFrame: Variation in sarcopenic index from baseline to 4 weeks
Secondary outcomes:
measure: Cardiovascular Risk Index
timeFrame: Variation in cardiovascular risk index from baseline to 4 weeks
measure: Homeostatic Model Assessment (HOMA-IR)
timeFrame: Variation in HOMA from baseline to 4 weeks
measure: Prognostic Inflammatory and Nutritional Index (PINI)
timeFrame: Variation in PINI from baseline to 4 weeks
measure: Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB)
timeFrame: Variation in expression of NFkappaB from baseline to 4 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata
Study officials:
References:
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