NUTRIBIOTA
Personalized Modulation of the Microbiota Through the Intelligent Design of Foods and Ingredients Based on Enterotype-Based Diagnosis (NUTRIBIOTA). Nutritional Intervention in Humans
Sponsor study identifier
interventional
60
1 country
1
Study Start
November 15, 2020
Actual (reported)Primary Completion
March 30, 2021
Actual (reported)Study Completion
May 15, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2020
Actual (reported)March 4, 2021
Actual (reported)March 16, 2021
Actual (reported)March 30, 2021
Actual (reported)May 15, 2021
Actual (reported)Change of fecal microbiota composition
Measured by analyzing the variable regions V3-V4 of the prokaryotic 16S rRNA (ribosomal ribonucleic acid) gene sequences, which gives 460 bp amplicons in a two-round PCR protocol. The kit used will be the Nextera® XT DNA Index Kit, FC-131-1002 (Illumina, San Diego, CA, USA). In the first step, PCR is used to amplify a template out of a DNA fecal sample using specific primers from Illumina. Then, sequencing libraries are built with the MiSeq® Reagent Kit v3 (600 cycles) MS-102-3003 (Illumina). Finally, paired-end sequencing is performed on a MiSeq platform (Illumina) with a 600 cycles Miseq run. Fecal samples are self-collected by the volunteers' fecal samples using OMNIgene.GUT kits from DNA Genotek (Ottawa, ONT, Canada), according to the standard instructions provided by the company
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of glucose concentration
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
The experimental group consumes the 4 foods designed for the study and will follow healthy eating guidelines.
The control group follows healthy 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.
To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group.
Center for Nutrition Research. University of Navarra
Pamplona, Navarre, Spain
Fermín Milagro Yoldi, PhD
University of Navarra
60 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2021
First Posted
March 16, 2021
Study Start
November 15, 2020
Actual (reported)Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
Change of total cholesterol concentration
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of LDL-cholesterol concentration
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of HDL-cholesterol concentration
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of triglyceride concentration
The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 30, 2021
Actual (reported)Study Completion
May 15, 2021
Actual (reported)Last Updated
February 3, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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