Effect of Consumption of a Novel Functional Yogurt on Blood Biomarkers of Healthy Participants (FB-CL1)

December 5, 2022 updated by: ANTONIOS KOUTELIDAKIS

Investigation of the Bioactivity of Yogurt Enriched With Probiotics and Polyphenols, Through Its Postprandial Effect on Specific Blood Biomarkers in Healthy Participants

The purpose of the study is to assess the effect of a dietary intervention that includes the consumption of a novel functional yogurt (enriched with probiotics and polyphenols) on the blood biomarkers of healthy participants.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

After having been informed about the study and the potential risks, all participants giving written informed consent will undergo screening to determine eligibility for study entry (inclusion criteria). At baseline (t0), a fasting blood sample will be taken by venipuncture from the participants, and they will be randomly assigned in a double-blind manner (investigator and participant) to one of the intervention groups, i.e. meal including the consumption of the functional yogurt (yogurt enriched with probiotics and polyphenols) or consumption of yogurt enriched with probiotics or consumption of placebo yogurt. The participants have to finish their meals within 15 minutes (t1) and after the meal, blood sampling will be repeated for the times, t2 = 30 min, t3 = 90 min, t4 = 180min. After a washout period of 7 days, the participants will consume the functional yogurt, or the yogurt enriched with probiotics, or the placebo yogurt, in a cross-over design, and the blood sampling will be carried out as described above. Finally, after a washout period of 7 days, the participants will consume the functional yogurt, or the yogurt enriched with probiotics or the placebo yogurt in a cross-over design, and the blood sampling will be carried out as described above. Throughout the interventional period participants' dietary intake, anthropometrical data, medical history, and dietary habits will be monitored.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Myrina, Greece, 81 400
        • University of the Aegean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-healthy individuals aged 18-65 years old, of both sexes/genders

Exclusion Criteria:

  • BMI > 30 kg/m^2
  • contraceptive pills taking
  • lactose intolerance or food allergy to any of the ingredients of the food under study
  • probiotic supplements or medications that affect bowel function
  • pregnant or lactating women
  • illicit drug use or chronic alcoholism or total daily alcohol intake > 50 g/d
  • people 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 individuals with any other serious medical condition that may affect their ability to participate in a dietary intervention study
  • individuals who are considered unreliable by the researcher or who have a shorter life expectancy than the expected duration of the study, due to some illness or if they are in any condition which in the researcher's opinion does not allow their safe participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yogurt enriched with probiotics and polyphenols
Participants will consume a meal including 200g of yogurt containing Lacticaseibacillus rhamnosus probiotics (3*10^9 cfu/g) immobilized on oat flakes (1g) and polyphenol-rich lyophilized extract (250mg) of Cistus Albidus (77,3 mg GAE/g), as well as two slices of white bread (80g) with butter (30g)
Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes and polyphenols
Participants will consume a meal including 200g of yogurt enriched with Lacticaseibacillus rhamnosus probiotics (3*10^9 cfu/g) immobilized on oat flakes (1g) and polyphenol-rich lyophilized extract (250mg) of Cistus Albidus (77,3 mg GAE/g), as well as two slices of white bread (80g) with butter (30g). Then blood biomarkers will be examined to determine the effect of functional yogurt on postprandial glycemia and lipemia
Active Comparator: Yogurt enriched with probiotics
Participants will consume a meal including 200g of yogurt containing Lacticaseibacillus rhamnosus probiotics (3*10^9 cfu/g) immobilized on oat flakes (1g), as well as two slices of white bread (80g) with butter (30g)
Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes
Participants will consume a meal including 200g of yogurt with Lacticaseibacillus rhamnosus probiotics (3*10^9 cfu/g) immobilized on oat flakes (1g), as well as two slices of white bread (80g) with butter (30g). Then blood biomarkers will be examined to determine the effect of probiotic-enriched yogurt on postprandial glycemia and lipemia.
Placebo Comparator: Plain yogurt with oat flakes
Participants will consume a meal including 200g of plain yogurt containing oat flakes (1g), as well as two slices of white bread (80g) with butter (30g)
Other: Consumption of a meal with plain Yogurt with oat flakes
Participants will consume a meal including 200g of plain yogurt containing 1g of oat flakes, as a placebo, as well as two slices of white bread (80g) with butter (30g). Then blood biomarkers will be examined to determine the effect of probiotic-enriched yogurt on postprandial glycemia and lipemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in metabolic health
Time Frame: 3 hours
Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption. Blood serum analysis will include assessment of lipidemic profile [i.e. Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG)], insulin, cortisol and uric acid.
3 hours
Change from baseline in blood glucose
Time Frame: 3 hours
Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption. Blood plasma analysis will include assessment of glucose metabolism [i.e. Fasting Blood Glucose (FBG)]
3 hours
Change from baseline in C-reactive protein (CRP)
Time Frame: 3 hours
Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption.
3 hours
Change from baseline in Oxidative stress
Time Frame: 3 hours
Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption and serum analysis will be conducted with a free radical analytical system
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANTONIOS KOUTELIDAKIS

Collaborators

Democritus University of Thrace
University of Ioannina

Investigators

  • Study Director: Antonios E. Koutelidakis, University of the Aegean

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Anticipated)

December 10, 2022

Study Completion (Anticipated)

December 16, 2022

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5047291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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