Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome (FOODBIOMES CT2)

February 27, 2024 updated by: University of the Aegean

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Limnos/Lesvos
      • Myrina, Limnos/Lesvos, Greece, 81 400
        • University of the Aegean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Conventional oat flakes-placebo
Other: Conventional oat flakes
Commercial oat flakes
Experimental: Probiotic oat flakes
Other: Probiotic oat flakes
2 x 10^9 cfu/g Lactococcus cremoris immobilized on oat flakes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Blood samples were collected by venipuncture at three time points; before intervention, at 6th and 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Aegean

Collaborators

Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 5047292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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