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临床试验/NCT05612243
NCT05612243Enrolling By Invitation不适用

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

ANTONIOS KOUTELIDAKIS2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
21
试验地点
2
主要终点
Change from baseline in metabolic health

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change from baseline in metabolic health

时间窗: 3 hours

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.

Change from baseline in C-reactive protein (CRP)

时间窗: 3 hours

Blood samples will be obtained after an overnight, 12-h fasting and 30, 90 and 180 min after meal consumption.

Change from baseline in blood glucose

时间窗: 3 hours

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 \[i.e. Fasting Blood Glucose (FBG)\]

Change from baseline in Oxidative stress

时间窗: 3 hours

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

次要结局

未报告次要终点

研究者

发起方
ANTONIOS KOUTELIDAKIS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ANTONIOS KOUTELIDAKIS

Assistant Professor

University of the Aegean

研究点 (2)

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