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

Healthy Clinical Trial

— FOODBIOMES CT2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06293859
• Other study ID #: 5047292
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: February 2024
• Source: University of the Aegean
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 30, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Probiotic oat flakes
2 x 10^9 cfu/g Lactococcus cremoris immobilized on oat flakes
• Conventional oat flakes
Commercial oat flakes

Locations

Country	Name	City	State
Greece	University of the Aegean	Myrina	Limnos/Lesvos

Sponsors (2)

Lead Sponsor	Collaborator
University of the Aegean	Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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