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

NCT01890070 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-12-10

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Hazelnuts

Italian hazelnuts from Piedmont with Protected Geographical Indication Certification

DIETARY_SUPPLEMENT

Chocolate

Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)

DIETARY_SUPPLEMENT

Red wine

Italian Organic Red Wine

DIETARY_SUPPLEMENT

Olive Oil

Italian Organic Olive Oil

DIETARY_SUPPLEMENT

Wild mixed greens

Italian organic wild mixed greens

DIETARY_SUPPLEMENT

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)

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01890070 on ClinicalTrials.gov