Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799223
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2021-03-04
Brief Title:
Personalized Modulation of Microbiota
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Personalized Modulation of the Microbiota Through the Intelligent Design of Foods and Ingredients Based on Enterotype-Based Diagnosis NUTRIBIOTA Nutritional Intervention in Humans
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUTRIBIOTA
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 2000 different bacteria species The gut microbiota plays a key in many of the bodys 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
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
Detailed Description:
The 60 volunteers participating in the study who meet the inclusion criteria will be randomly divided into two groups
Control group nutritional promotion volunteers will be provided with basic nutritional recommendations based on a Mediterranean diet
Experimental group Nutribiota volunteers will be instructed to follow a dietary strategy similar to the control group but including the functional foods and ingredients developed by the companies with the aim to promote a balanced and specific diet associated with improvements in the composition of the microbiota and metabolic parameters of the volunteers
The duration of the study are 8 weeks during which 4 visits are scheduled
Recruitment this visit will consist on an initial screening in which the volunteers will be informed about the characteristics of the study and will be receive the information sheet and the informed consent form to be signed by all those interested in participating in the study Volunteers who meet the inclusion for the study will be asked to complete the Food Frequency Questionnaire and Physical Activity Questionnaire for the next visit visit 1 In addition each participant will be provided with a faecal microbiota sample collection kit which they will have to hand in with the corresponding sample at the next visit visit 1
Clinical investigation day 1 week 0after a fasting period of at least 10 hours the nursing staff will take a blood sample to analyze the biochemical parameters and metabolomic profile Anthropometric measurements will be taken from each volunteer weight height waist and hip circumference and body composition analysis by bioimpedance with the collaboration of a dietician In addition faecal sample and Food Frequency Questionnaire and Physical Activity Questionnaire will be collected Volunteers randomly assigned to the experimental group will be given the dishes and functional ingredients designed by the companies which they will have to incorporate into a balanced dietary pattern following the indications given by the dietician
Clinical investigation day 2 week 4 In this visit the adherence of the volunteers to the study will be monitored and the weight of the volunteers will be registered In addition all study volunteers will be given a faecal microbiota sample collection kit which should be handed in with the corresponding sample at the final visit Moreover Food Frequency Questionnaire and Physical Activity Questionnaire will be given to each volunteer in order to be filled for the final visit Volunteers who belong to the experimental group will be given dishes and functional ingredients
Clinical investigation day 3 week 8 Faecal sample Food Frequency Questionnaire and Physical Activity Questionnaire will be collected The procedures in this visit will be the same as in visit 1 but dishes and functional ingredients will not be given to the volunteers
Control group nutritional promotion volunteers will be provided with basic nutritional recommendations based on a Mediterranean diet
Experimental group Nutribiota volunteers will be instructed to follow a dietary strategy similar to the control group but including the functional foods and ingredients developed by the companies with the aim to promote a balanced and specific diet associated with improvements in the composition of the microbiota and metabolic parameters of the volunteers
The duration of the study are 8 weeks during which 4 visits are scheduled
Recruitment this visit will consist on an initial screening in which the volunteers will be informed about the characteristics of the study and will be receive the information sheet and the informed consent form to be signed by all those interested in participating in the study Volunteers who meet the inclusion for the study will be asked to complete the Food Frequency Questionnaire and Physical Activity Questionnaire for the next visit visit 1 In addition each participant will be provided with a faecal microbiota sample collection kit which they will have to hand in with the corresponding sample at the next visit visit 1
Clinical investigation day 1 week 0after a fasting period of at least 10 hours the nursing staff will take a blood sample to analyze the biochemical parameters and metabolomic profile Anthropometric measurements will be taken from each volunteer weight height waist and hip circumference and body composition analysis by bioimpedance with the collaboration of a dietician In addition faecal sample and Food Frequency Questionnaire and Physical Activity Questionnaire will be collected Volunteers randomly assigned to the experimental group will be given the dishes and functional ingredients designed by the companies which they will have to incorporate into a balanced dietary pattern following the indications given by the dietician
Clinical investigation day 2 week 4 In this visit the adherence of the volunteers to the study will be monitored and the weight of the volunteers will be registered In addition all study volunteers will be given a faecal microbiota sample collection kit which should be handed in with the corresponding sample at the final visit Moreover Food Frequency Questionnaire and Physical Activity Questionnaire will be given to each volunteer in order to be filled for the final visit Volunteers who belong to the experimental group will be given dishes and functional ingredients
Clinical investigation day 3 week 8 Faecal sample Food Frequency Questionnaire and Physical Activity Questionnaire will be collected The procedures in this visit will be the same as in visit 1 but dishes and functional ingredients will not be given to the volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None