Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811157
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-18
Brief Title:
The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
Sponsor:
Center of Food and Fermentation Technologies
Organization:
Center of Food and Fermentation Technologies
Study Overview
Official Title:
The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier
Hypothesis 1 Intake of dietary fibers improves the blood lipid profile of the participants
Hypothesis 2 Intake of dietary fibers stabilizes the gut microbiome eg low diversity of the participants improves gut health and normalizes gastrointestinal function and bowel habits
Hypothesis 1 Intake of dietary fibers improves the blood lipid profile of the participants
Hypothesis 2 Intake of dietary fibers stabilizes the gut microbiome eg low diversity of the participants improves gut health and normalizes gastrointestinal function and bowel habits
Detailed Description:
The study design is a parallel randomized prospective pre-post intervention trial The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt Fermented dairy products have naturally a very low dietary fiber content but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria Also as fermented milk products contain live bacteria it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut
PRE-STUDY EVALUATION AND TESTING
1 Complete pre-study questionnaire
2 Complete orientation to the study and provide voluntary consent to join the study
3 Collection of coded intervention products sampling supplies and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1 Record food intake and gastrointestinal function for 3 days 2 Collect health data and provide a 3-day food frequency questionnaire 3 Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1 Record food intake and gastrointestinal symptoms for 3 days
2 Collect health data and provide a 3-day food frequency questionnaire
3 Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
1 Provide the blood sample at the laboratory in the morning in an overnight fasted state
DIETARY INTERVENTION
1 Daily intake of a test or control product for two weeks
PRE-STUDY EVALUATION AND TESTING
1 Complete pre-study questionnaire
2 Complete orientation to the study and provide voluntary consent to join the study
3 Collection of coded intervention products sampling supplies and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1 Record food intake and gastrointestinal function for 3 days 2 Collect health data and provide a 3-day food frequency questionnaire 3 Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1 Record food intake and gastrointestinal symptoms for 3 days
2 Collect health data and provide a 3-day food frequency questionnaire
3 Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
1 Provide the blood sample at the laboratory in the morning in an overnight fasted state
DIETARY INTERVENTION
1 Daily intake of a test or control product for two weeks
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