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

University of the Aegean

Status

Completed

Conditions

Healthy

Treatments

Other: Conventional oat flakes

Other: Probiotic oat flakes

Study type

Interventional

Funder types

Other

Identifiers

NCT06293859

5047292

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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).