Personalized Modulation of Microbiota

NCT04799223 | Completed

• 1 other identifier: NUTRIBIOTA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Fecal microbiota; Nutrition; Diet; Insulin

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (16)

• 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).

• 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).

Study Arms (2)

Group receiving the 4 designed foods

EXPERIMENTAL

The experimental group consumes the 4 foods designed for the study and will follow healthy eating guidelines.

Other: Four-foods eating guidelines

Group with no designed foods

ACTIVE COMPARATOR

The control group follows healthy eating guidelines.

Other: No designed-foods eating guidelines

Interventions

Four-foods eating guidelines OTHER

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.

Group receiving the 4 designed foods

No designed-foods eating guidelines OTHER

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

Group with no designed foods

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers of both sexes with ages between 20 and 65 years.
• Volunteers with a body mass index between 24.9 and 34.9 kg / m2.
• Volunteers with intestinal dysbiosis.
• Physical examination and normal vital signs or clinically irrelevant for the study.
• Subjects must be able to understand and be willing to sign the informed consent.

You may not qualify if:

• Volunteers who have taken antibiotics or corticosteroids one month before the start of the intervention or antihistamines 15 days before the start of the intervention.
• Volunteers who are taken gastric protectors chronically.
• Volunteers who present changes in their pharmacological treatment in the last 3 months before the start of the study.
• Volunteers with intestinal pathologies (ulcerative colitis, Crohn's disease, or similar).
• Volunteers suffering from Covid-19

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, Spain

Location

MeSH Terms

Conditions

Obesity; Communicable Diseases; Nutrition Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Fermín Milagro Yoldi, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 16, 2021
• Study Start: November 15, 2020
• Primary Completion: March 30, 2021
• Study Completion: May 15, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)