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

NCT ID: NCT06293859

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional oat flakes-placebo

Group Type: PLACEBO_COMPARATOR

Conventional oat flakes

Intervention Type: OTHER

Commercial oat flakes

Probiotic oat flakes

Group Type: EXPERIMENTAL

Probiotic oat flakes

Intervention Type: OTHER

2 x 10\^9 cfu/g Lactococcus cremoris immobilized on oat flakes

Interventions

Probiotic oat flakes

2 x 10\^9 cfu/g Lactococcus cremoris immobilized on oat flakes

Intervention Type: OTHER

Conventional oat flakes

Commercial oat flakes

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: collaborator

University of the Aegean

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of the Aegean

Myrina, Limnos/Lesvos, Greece

Countries

Greece

Other Identifiers

5047292

Identifier Type: -

Identifier Source: org_study_id