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

NCT06293859 | Completed

• 1 other identifier: 5047292
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional oat flakes-placebo

PLACEBO COMPARATOR

Other: Conventional oat flakes

Probiotic oat flakes

EXPERIMENTAL

Other: Probiotic oat flakes

Interventions

Probiotic oat flakes OTHER

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

Probiotic oat flakes

Conventional oat flakes OTHER

Commercial oat flakes

Conventional oat flakes-placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of the Aegean: lead
• Democritus University of Thrace: collaborator

Study Sites (1)

University of the Aegean

Myrina, Limnos/Lesvos, 81 400, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: February 15, 2023
• Primary Completion: July 7, 2023
• Study Completion: July 30, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)