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Personalized Modulation of Microbiota

NCT04799223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Obesity
  • Microbial Colonization
  • Nutrition Disorders

Interventions

OTHER

Four-foods eating guidelines

To follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern.

OTHER

No designed-foods eating guidelines

To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group.

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Fermín Milagro Yoldi, PhD · University of Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2021-03-30
Completion
2021-05-15

Countries

  • Spain

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 NCT04799223 on ClinicalTrials.gov