Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT04280731

Collaborator

Swedish International Development Cooperation Agency (SIDA) (Other)

Enrollment

Location

Arm

5.4

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization	Dietary Supplement: fermented quinoa	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora

Actual Study Start Date :

Jan 7, 2020

Actual Primary Completion Date :

Jun 20, 2020

Actual Study Completion Date :

Jun 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fermented drink	Dietary Supplement: fermented quinoa Quinoa drink fermented with lactic acid bacteria isolated from food

Arm

Intervention/Treatment

Experimental: Fermented drink

Dietary Supplement: fermented quinoa

Quinoa drink fermented with lactic acid bacteria isolated from food

Outcome Measures

Primary Outcome Measures

Survivability of the lactic acid bacteria [2 weeks]
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 [2 weeks]
Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism
Changes in the human microbiota [2 weeks]
Changes in the saliva and stool samples by quantitative polymorphic chain reaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Above 18 years and healthy volunteers

Exclusion Criteria:

Participants that have any kind of diseases, such as colon inflammation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kemicentrum	Lund	Skåne	Sweden	223 62

Sponsors and Collaborators

Lund University
Swedish International Development Cooperation Agency (SIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Åsa Håkansson, Principal Investigator, Lund University

ClinicalTrials.gov Identifier:

NCT04280731

Other Study ID Numbers:

FermCH

First Posted:

Feb 21, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Study Results

No Results Posted as of Oct 5, 2020