- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280731
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skåne
-
Lund, Skåne, Sweden, 223 62
- Kemicentrum
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Above 18 years and healthy volunteers
Exclusion Criteria:
- Participants that have any kind of diseases, such as colon inflammation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fermented drink
|
Quinoa drink fermented with lactic acid bacteria isolated from food
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survivability of the lactic acid bacteria
Time Frame: 2 weeks
|
If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the human microbiota
Time Frame: 2 weeks
|
Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism
|
2 weeks
|
Changes in the human microbiota
Time Frame: 2 weeks
|
Changes in the saliva and stool samples by quantitative polymorphic chain reaction
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FermCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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