At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Beneficial Effect of Mediterranean (MD) Components on the Structure and Functions of Gut Microbiome and Metabolome in Subjects With Low Adherence to MD
In Brief
A clinical study evaluating Placebo and SuperFood for Microbiota and 2 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Western dietary patterns including a high consumption of red and processed meat, refined grains and sugars, and dairy products have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.
Study Details
Timeline
Interventions
The group will have to consume a jar every day (approx. 75 ml) which contain (water, malt-dextrins, 0.1% starch, 0.1% guar gum, flavorings and colorants)
The group will have to consume a jar of superfood (vegetable smoothie) every day. The jar will be filled with approx. 75 ml which corresponds to about 75 g. The superfood formulated by the University of Bolzano on the basis of the results and evidence acquired in collaboration with the Istituto Superiore di Sanità. Composition: pomegranate, walnuts, moringa, broccoli, according to the proportions indicated in Annex 2. This mixture has been analyzed by an external laboratory and authorized for human use