HealthyFOODBIOMES CT2NCT06293859
Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome
A study testing Probiotic oat flakes and Conventional oat flakes in people with Healthy, run by University of the Aegean at 1 site in Greece.
Trial summary
The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic oat flakes and Conventional oat flakes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2023to 30 Jul 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants to be aged between 18 and 65 years
- clinically tested with fasting plasma glucose less than 100 mg/dL
- clinically tested withcholesterol less than 220 mg/dL
- otherwise healthy
Who cannot join
- body mass index [BMI] higher than 40 kg/m2 (morbidly obese)
- following a diet plan for weight loss
- following a contraceptive treatment or taking probiotic supplements
- following medication with an effect on lipaemia or glycemia indicators
- having any allergies/intolerances to trial ingredients
- pregnant or planning to become pregnant or breast feeding
Show all 9Show fewer
- users of illicit drug, having a chronic alcoholism or total daily alcohol intake more than 50 g per day
- diagnosed with a chronic condition (cancer, active liver disease, severe kidney dysfunction, severe stroke in the last six months and conditions associated with an increased risk of bleeding) or any other serious medical condition that may affect the individual's ability to participate in a dietary intervention study
- considered unreliable by the researcher or having a shorter life expectancy than the expected duration of the study due to some illness or if they were in any situation in which by the researcher's opinion their participation in the study was not considered safe (e.g. drug addiction, alcohol abuse).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Daily Lactococcus Cremoris Spp. Consumption Immobilized in Oat Flakes on Blood and Urine Biomarkers and Human Microbiome: a Randomized Placebo-controlled Clinical Trial
The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health.
Read the detailed description
All eligible and consenting individuals were assigned a unique code for identification purposes. They were then randomly assigned to either the probiotic or placebo group. The probiotic group received oat flakes containing immobilized Lactococcus cremoris, while the placebo group received oat flakes indistinguishable in color, smell, and taste from the flakes with immobilized probiotics.Participants received written instructions on storing the product, which required refrigeration. They were instructed to consume 5 g of oats daily with a meal, ensuring the meal's temperature remained below 35 °C and was non-acidic (e.g., with yogurt). Biological samples were collected at three time points; before intervention, at 6th and 12th week.
- Conditions
- Healthy
- Being tested
- Probiotic oat flakes, Conventional oat flakes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic oat flakesOther
2 x 10^9 cfu/g Lactococcus cremoris immobilized on oat flakes
Conventional oat flakesOther
Commercial oat flakes
| Study group | Role | What they receive |
|---|---|---|
| Conventional oat flakes-placebo | Placebo comparator | Not described Receives: Other: Conventional oat flakes |
| Probiotic oat flakes | Experimental | Not described Receives: Other: Probiotic oat flakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers
Change from baseline of hs-CRP and IL-6
Measured: Blood samples were collected by venipuncture at three time points; before intervention, at 6th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start15 Feb 2023
- Primary completion7 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Aegean
- Sponsor type
- University, hospital or other
- Collaborators
- Democritus University of Thrace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293859
- Sponsor's protocol ID
- 5047292
- Acronym
- FOODBIOMES CT2
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Lactococcus Cremoris Spp. Consumption Immobilized in Oat Flakes on Blood and Urine Biomarkers and Human Microbiome: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06293859
- Acronym / sponsor ID
- FOODBIOMES CT2 / 5047292
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of the AegeanUniversity, hospital or other
- Collaborators
- Democritus University of Thrace
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Mar 2024 (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 purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health.
Detailed description
All eligible and consenting individuals were assigned a unique code for identification purposes. They were then randomly assigned to either the probiotic or placebo group. The probiotic group received oat flakes containing immobilized Lactococcus cremoris, while the placebo group received oat flakes indistinguishable in color, smell, and taste from the flakes with immobilized probiotics.Participants received written instructions on storing the product, which required refrigeration. They were instructed to consume 5 g of oats daily with a meal, ensuring the meal's temperature remained below 35 °C and was non-acidic (e.g., with yogurt). Biological samples were collected at three time points; before intervention, at 6th and 12th week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional oat flakes-placebo | Placebo comparator | Other: Conventional oat flakes |
| Probiotic oat flakes | Experimental | Other: Probiotic oat flakes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants to be aged between 18 and 65 years
- clinically tested with fasting plasma glucose less than 100 mg/dL
- clinically tested withcholesterol less than 220 mg/dL
- otherwise healthy
Key exclusion criteria (9 listed)
- body mass index [BMI] higher than 40 kg/m2 (morbidly obese)
- following a diet plan for weight loss
- following a contraceptive treatment or taking probiotic supplements
- following medication with an effect on lipaemia or glycemia indicators
- having any allergies/intolerances to trial ingredients
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 |
|---|---|---|
| Probiotic oat flakes2 x 10^9 cfu/g Lactococcus cremoris immobilized on oat flakes | Other | Probiotic oat flakes |
| Conventional oat flakesCommercial oat flakes | Other | Conventional oat flakes-placebo |
Primary outcome
Inflammatory biomarkers
Time frame: Blood samples were collected by venipuncture at three time points; before intervention, at 6th and 12th week
Change from baseline of hs-CRP and IL-6
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 Mar 2024.
- Individual participant dataSharing planned: No
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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 Probiotic oat flakes and Conventional oat flakes in people with Healthy, run by University of the Aegean at 1 site in Greece.
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 4 inclusion and 9 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 Mar 2024. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Inflammatory biomarkers (time frame: Blood samples were collected by venipuncture at three time points; before intervention, at 6th and 12th week). 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 Mar 2024.