Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626997
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of a SYMBIOTIC DRINK on the MICROBIOTA and DIFFERENT NUTRITIONAL MARKERS in HEALTHY VOLUNTEERS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of a SYMBIOTIC DRINK on the MICROBIOTA and DIFFERENT NUTRITIONAL MARKERS in HEALTHY VOLUNTEERS
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOMFIBRA
Brief Summary:
This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group which will consume the fermented drink and a control group which will consume a drink with similar characteristics but without the presence of bioactive components
Detailed Description:
At the beginning of the trial you will have an interview screening visit with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it If it is confirmed that you meet the criteria to participate in the study after your assent and informed consent have been obtained you will be able to do so At the first visit you will be assigned a code by a random method computerized and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None