Effect of Consumption of a Novel Functional Yogurt on Blood Biomarkers of Healthy Participants

Not Applicable

• Conditions: Healthy
• Interventions: Other: Consumption of a meal with plain Yogurt with oat flakes; Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes and polyphenols; Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes

• Registration Number: NCT05612243
• Lead Sponsor: ANTONIOS KOUTELIDAKIS

Brief Summary

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.

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 Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-16

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plain yogurt with oat flakes	Consumption of a meal with 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)
Yogurt enriched with probiotics and polyphenols	Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes 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)
Yogurt enriched with probiotics	Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes	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)

Primary Outcome Measures

Name	Time	Method
Change from baseline in metabolic health	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.
Change from baseline in C-reactive protein (CRP)	3 hours	Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption.
Change from baseline in blood glucose	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 \[i.e. Fasting Blood Glucose (FBG)\]
Change from baseline in Oxidative stress	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

Trial Locations

Locations (1)

University of the Aegean; 🇬🇷 Myrina, Greece