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

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: Healthy
• Intervention / Treatment: Other: Conventional oat flakes; Other: Probiotic oat flakes

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: University of the Aegean
• Collaborators: Democritus University of Thrace

Study record dates

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