NCT05451992: SUPERFOOD 19-2

Microbiome-Tailored Food Products Based On Typical Mediterranean Diet Components

Completed NA Last updated 11 July 2022

What this trial tests

NA trial testing Placebo in Microbiota in 40 participants. Completed in 15 December 2021.

Timeline

15 February 2021

Primary endpoint
15 April 2021

15 December 2021

Quick facts

Lead sponsor	University of Bari
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	15 February 2021
Primary completion	15 April 2021
Estimated completion	15 December 2021
Sites	1 location across Italy

Drugs / interventions tested

• Placebo
• SuperFood

Conditions studied

• Microbiota — all drugs for Microbiota →
• Overweight and Obesity — all drugs for Overweight and Obesity →
• Metabolic Complication — all drugs for Metabolic Complication →

Sponsor

University of Bari

Who can join

Adults 30 to 60, any sex, with Microbiota or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.