Investigation of the Bioactivity of Yogurt Enriched With Probiotics and Polyphenols, Through Its Postprandial Effect on Specific Blood Biomarkers in Healthy Participants
| Registry | NCT05612243, acronym FB-CL1 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, health services research |
| Enrollment | 21 (Estimated) |
| Sponsor | ANTONIOS KOUTELIDAKIS (Other); collaborators: Democritus University of Thrace, University of Ioannina |
| Conditions | Healthy |
| Interventions | Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes and polyphenols, Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes, Consumption of a meal with plain Yogurt with oat flakes (Other) |
| Dates | start 2022-10-17, primary completion 2022-12-10 (estimated), completion 2022-12-16 (estimated), first posted 2022-11-10, last updated 2022-12-06 |
| Locations | 1 site in Greece |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Yogurt enriched with probiotics and polyphenols | Experimental | 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 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 | Active comparator | Other: 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) |
| Plain yogurt with oat flakes | Placebo comparator | Other: 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) |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of the Aegean | Myrina | Greece |