Back to resultsImpact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
Primary Purpose
Microbial Colonization
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
fermented quinoa
Sponsored by
About this trial
This is an interventional basic science trial for Microbial Colonization
Eligibility Criteria
Inclusion Criteria:
- Above 18 years and healthy volunteers
Exclusion Criteria:
- Participants that have any kind of diseases, such as colon inflammation
Sites / Locations
- Kemicentrum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fermented drink
Arm Description
Outcomes
Primary Outcome Measures
Survivability of the lactic acid bacteria
If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar
Secondary Outcome Measures
Changes in the human microbiota
Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism
Changes in the human microbiota
Changes in the saliva and stool samples by quantitative polymorphic chain reaction
Full Information
NCT ID
NCT04280731
First Posted
December 4, 2019
Last Updated
October 1, 2020
Sponsor
Lund University
Collaborators
Swedish International Development Cooperation Agency (SIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04280731
Brief Title
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
Official Title
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Swedish International Development Cooperation Agency (SIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The demand for alternatives to dairy products has increased in recent years and a lot of proposals for vegetable milk and yogurt products have taken place in the market. Quinoa is a plant from South America that has growth in popularity in recent years as many sought out nutritious and healthier eating, the herb is known for its high nutritional value. It is complete protein source containing all the essential amino acids. If this herb were fermented with probiotic bacteria, there is a potential for a product that is lactose free, gluten free and cholesterol free.
The probiotic potential of quinoa milk, fermented with food associated lactic acid bacteria will be investigated. This includes a study that examines how daily consumption of this vegetable drink changes the composition of the oral and intestinal flora. Therefore, healthy people are now seeking to participate in the study, which will be for just over 2 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fermented drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
fermented quinoa
Intervention Description
Quinoa drink fermented with lactic acid bacteria isolated from food
Primary Outcome Measure Information:
Title
Survivability of the lactic acid bacteria
Description
If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Changes in the human microbiota
Description
Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism
Time Frame
2 weeks
Title
Changes in the human microbiota
Description
Changes in the saliva and stool samples by quantitative polymorphic chain reaction
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Above 18 years and healthy volunteers
Exclusion Criteria:
Participants that have any kind of diseases, such as colon inflammation
Facility Information:
Facility Name
Kemicentrum
City
Lund
State/Province
Skåne
ZIP/Postal Code
223 62
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
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