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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01890070
• Other study ID #: DM 06/12/2011 n° prot. 32064
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2013
• Last updated: December 9, 2015
• Start date: May 2013

Study information

• Verified date: December 2015
• Source: University of Rome Tor Vergata
• Contact: Laura Di Renzo, PhD
• Phone: +39 0672596855
• Email: laura.di.renzo[@]uniroma2.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Hazelnuts
Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
• Chocolate
Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
• Red wine
Italian Organic Red Wine
• Olive Oil
Italian Organic Olive Oil
• Wild mixed greens
Italian organic wild mixed greens
• Chestnut
Italian Organic Chestnut

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)

Locations

Country	Name	City	State
Italy	Clinical Nutrition and Nutrigenomic, School of Medicine University of Rome Torvergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sarcopenic index	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	No
Secondary	Cardiovascular Risk Index	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	No
Secondary	Homeostatic Model Assessment (HOMA-IR)	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	No
Secondary	Prognostic Inflammatory and Nutritional Index (PINI)	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	No
Secondary	Nuclear factor kappa-light-chain-enhancer of activated B cells (NFkappaB)	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	No