NCT06293859

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of the Aegean · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Probiotic oat flakes	2 x 10\^9 cfu/g Lactococcus cremoris immobilized on oat flakes
OTHER	Conventional oat flakes	Commercial oat flakes

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-07-07
• Completion: 2023-07-30
• First posted: 2024-03-05
• Last updated: 2024-03-05

Locations

1 site across 1 country: Greece