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
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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