Microbial ColonizationNCT04280731
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
A study testing fermented quinoa in people with Microbial Colonization, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- fermented quinoa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jan 2020to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years and healthy volunteers
Who cannot join
- Participants that have any kind of diseases, such as colon inflammation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Microbial Colonization
- Being tested
- fermented quinoa
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented quinoaDietary supplement
Quinoa drink fermented with lactic acid bacteria isolated from food
| Study group | Role | What they receive |
|---|---|---|
| Fermented drink | Experimental | Not described Receives: Dietary Supplement: fermented quinoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivability of the lactic acid bacteria
If the bacteria can be isolated in a adequate amount by cultivation on MRS broth and rogosa agar
Measured: 2 weeks
Secondary outcomes (2)
Changes in the human microbiota
Changes in the saliva and stool samples by analyzes with Terminal Restriction Fragment Length polymorphism
Measured: 2 weeks
Changes in the human microbiota
Changes in the saliva and stool samples by quantitative polymorphic chain reaction
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start7 Jan 2020
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Responsible party
- Principal investigator, Åsa Håkansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280731
- Sponsor's protocol ID
- FermCH
- Status last verified
- Oct 2020
- First submitted
- 4 Dec 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
- ClinicalTrials.gov ID
- NCT04280731
- Acronym / sponsor ID
- FermCH
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fermented drink | Experimental | Dietary Supplement: fermented quinoa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Above 18 years and healthy volunteers
Key exclusion criteria (1 listed)
- Participants that have any kind of diseases, such as colon inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fermented quinoaQuinoa drink fermented with lactic acid bacteria isolated from food | Dietary supplement | Fermented drink |
Primary outcome
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 secondary outcomes
Changes in the human microbiota
Time frame: 2 weeks
Changes in the human microbiota
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Microbial Colonization
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented quinoa in people with Microbial Colonization, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivability of the lactic acid bacteria (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.