NCT04799223: NUTRIBIOTA

Personalized Modulation of Microbiota

Completed NA Last updated 3 February 2023

What this trial tests

NA trial testing Four-foods eating guidelines in Obesity in 60 participants. Completed in 15 May 2021.

Timeline

15 November 2020

Primary endpoint
30 March 2021

15 May 2021

Quick facts

Lead sponsor	Clinica Universidad de Navarra, Universidad de Navarra
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	15 November 2020
Primary completion	30 March 2021
Estimated completion	15 May 2021
Sites	1 location across Spain

Drugs / interventions tested

• Four-foods eating guidelines
• No designed-foods eating guidelines

Conditions studied

• Obesity — all drugs for Obesity →
• Microbial Colonization — all drugs for Microbial Colonization →
• Nutrition Disorders — all drugs for Nutrition Disorders →

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

Adults 20 to 65, any sex, with Obesity or Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Hence, the analysis of the gut microbiome provides insight into the state of the microbiota as an indicator of overall health due to its metabolic, protective and nutritional functions. A balanced diet promotes the formation and maintenance of a well-structured microbiota, in which the different species of microorganisms cohabit in a balanced and controlled system.

The study is based on the hypothesis that the intake of certain plant-based foods rich in various active ingredients (especially non-digestible carbohydrates, certain types of fats and polyphenols) can modulate the microbiota and thus improve the health status of the human population.

Taking into account this background, the objective of this study is to assess the effect of the inclusion of functional foods and ingredients within a balanced diet on the composition of the microbiota and also on health parameters associated with metabolic disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gut microbiota modulatory capacity of Brassica oleracea italica x alboglabra (Bimi ® )
   Rosés C, Viadel B, Nieto JA, Soriano-Romaní L, et al · · 2023 · DOI 10.21203/rs.3.rs-2858830/v1