Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Democritus University of Thrace | OTHER |
| University of Ioannina | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
-healthy individuals aged 18-65 years old, of both sexes/genders
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antonios E. Koutelidakis | University of the Aegean | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Aegean | Myrina | 81 400 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32016250 | Background | 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. | |
| 24368433 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
|
| 31029925 | 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. |
| ID | Term |
|---|---|
| D059808 | Polyphenols |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided