Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 5:13 PM
Study NCT ID:
NCT04811157
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 (e.g., 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 (e.g., 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:
False
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?: