Clinical trial NCT05612243: Effect of Consumption of a Novel Functional Yogurt on Blood Biomarkers of Healthy Participants
Official title: Investigation of the Bioactivity of Yogurt Enriched With Probiotics and Polyphenols, Through Its Postprandial Effect on Specific Blood Biomarkers in Healthy Participants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: probiotics
antioxidants
blood biomarkers
functional yogurt
postprandial effect
polyphenols
Lead sponsor: University of the Aegean
Sponsor class: OTHER
Collaborators: name: Democritus University of Thrace
name: University of Ioannina
First posted: 2022-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from baseline in metabolic health
timeFrame: 3 hours
measure: Change from baseline in blood glucose
timeFrame: 3 hours
measure: Change from baseline in C-reactive protein (CRP)
timeFrame: 3 hours
measure: Change from baseline in Oxidative stress
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Myrina
country: Greece
facility: University of the Aegean
Study officials:
affiliation: University of the Aegean
name: Antonios E. Koutelidakis
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.