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

Healthy Clinical Trial

— FB-CL1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05612243
• Other study ID #: 5047291
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2022
• Source: University of the Aegean
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 21
• Est. completion date: December 16, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
Greece	University of the Aegean	Myrina

Sponsors (3)

Lead Sponsor	Collaborator
ANTONIOS KOUTELIDAKIS	Democritus University of Thrace, University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Annuzzi G, Bozzetto L, Costabile G, Giacco R, Mangione A, Anniballi G, Vitale M, Vetrani C, Cipriano P, Della Corte G, Pasanisi F, Riccardi G, Rivellese AA. Diets naturally rich in polyphenols improve fasting and postprandial dyslipidemia and reduce oxidative stress: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):463-71. doi: 10.3945/ajcn.113.073445. Epub 2013 Dec 24. — View Citation

Fidelix M, Milenkovic D, Sivieri K, Cesar T. Microbiota modulation and effects on metabolic biomarkers by orange juice: a controlled clinical trial. Food Funct. 2020 Feb 26;11(2):1599-1610. doi: 10.1039/c9fo02623a. — View Citation

Gomes APO, Ferreira MA, Camargo JM, Araujo MO, Mortoza AS, Mota JF, Coelho ASG, Capitani CD, Coltro WKT, Botelho PB. Organic beet leaves and stalk juice attenuates HDL-C reduction induced by high-fat meal in dyslipidemic patients: A pilot randomized controlled trial. Nutrition. 2019 Sep;65:68-73. doi: 10.1016/j.nut.2019.03.004. Epub 2019 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in metabolic health	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
Primary	Change from baseline in blood glucose	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
Primary	Change from baseline in C-reactive protein (CRP)	Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption.	3 hours
Primary	Change from baseline in Oxidative stress	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