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

NCT ID: NCT05612243

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2022-12-16

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes and polyphenols

Intervention Type: OTHER

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

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)

Group Type: ACTIVE_COMPARATOR

Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes

Intervention Type: OTHER

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.

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)

Group Type: PLACEBO_COMPARATOR

Consumption of a meal with plain Yogurt with oat flakes

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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 Ioannina

OTHER

Sponsor Role: collaborator

ANTONIOS KOUTELIDAKIS

OTHER

Sponsor Role: lead

Responsible Party

ANTONIOS KOUTELIDAKIS

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonios E. Koutelidakis

Role: STUDY_DIRECTOR

University of the Aegean

Locations

University of the Aegean

Myrina, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 32016250 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24368433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31029925 (View on PubMed)

Other Identifiers

5047291

Identifier Type: -

Identifier Source: org_study_id