NCT04280731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

December 4, 2019

Last Update Submit

October 1, 2020

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

  • Survivability of the lactic acid bacteria

    If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar

    2 weeks

Secondary Outcomes (2)

  • Changes in the human microbiota

    2 weeks

  • Changes in the human microbiota

    2 weeks

Study Arms (1)

Fermented drink

EXPERIMENTAL
Dietary Supplement: fermented quinoa

Interventions

fermented quinoaDIETARY_SUPPLEMENT

Quinoa drink fermented with lactic acid bacteria isolated from food

Fermented drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years and healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kemicentrum

Lund, Skåne County, 223 62, Sweden

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2019

First Posted

February 21, 2020

Study Start

January 7, 2020

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)