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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of the Bioactivity of Yogurt Enriched With Probiotics and Polyphenols, Through Its Postprandial Effect on Specific Blood Biomarkers in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes and polyphenols
* Other: Consumption of a meal with yogurt enriched with probiotics immobilized on oat flakes
* Other: Consumption of a meal with plain Yogurt with oat flakes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yogurt enriched with probiotics and polyphenols<br>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<br>* 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<br>|
| Active Comparator: Yogurt enriched with probiotics<br>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<br>* 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.<br>|
| Placebo Comparator: Plain yogurt with oat flakes<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, antioxidants, blood biomarkers, functional yogurt, postprandial effect, polyphenols