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

NCT05612243 | Unknown

• 1 other identifier: 5047291
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

probiotics; antioxidants; blood biomarkers; functional yogurt; postprandial effect; polyphenols

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Yogurt enriched with probiotics and polyphenols

EXPERIMENTAL

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

Yogurt enriched with probiotics

ACTIVE COMPARATOR

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

Plain yogurt with oat flakes

PLACEBO COMPARATOR

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

Interventions

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

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

Yogurt enriched with probiotics

Consumption of a meal with plain Yogurt with oat flakes 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.

Plain yogurt with oat flakes

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANTONIOS KOUTELIDAKIS: lead
• Democritus University of Thrace: collaborator
• University of Ioannina: collaborator

Study Sites (1)

University of the Aegean

Myrina, 81 400, Greece

Location

Related Publications (3)

• 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.

  PMID: 32016250 BACKGROUND

• 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.

  PMID: 24368433 BACKGROUND

• 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.

  PMID: 31029925 BACKGROUND

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Antonios E. Koutelidakis

  University of the Aegean

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: October 17, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 16, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

GR (1)