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临床试验/NCT05715008
NCT05715008尚未招募不适用

The Effect of Kefir Consumption on Anthropometric, Physiological and Oxidative Stress Parameters in Adults Subjects

University of Thessaly0 个研究点目标入组 16 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
主要终点
Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo.

研究概览

简要总结

The purpose of this study is to examine the effect of kefir consumption on anthropometric, physiological and redox status parameters in adult subjects, and compare it with the intake of placebo drink (milk).

详细描述

Importance of the research

Several chronic diseases are related with alterations in redox status. Over the years several nutritional approaches have been implemented in order to examine modulation of the redox status. Kefir is a product that can alter the gut microbiome and potentially affect the redox status. This study will help elucidate whether the consumption of a dairy product (kefir) will modulate anthropometric, physiological and oxidative stress parameters.

Methodology

  1. Sample:

The study will involve 16 adult volunteers, (8-experimental group and 8-control group), aged 20-60 years. The subjects will participate in a double-blind, randomized study, where in one condition they will receive kefir (300 ml per day - 150 ml in the morning and 150 ml in the evening) and in the next condition they will receive regular cow milk as a placebo. 2. Process of collecting results:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • The persons selected will be volunteers.
  • The use of alcohol and smoking will be prohibited during the experiment.
  • Participation in other sports activities will also not be allowed.
  • In the last six months they should not have taken any medication that affect the redox status, as well as dietary supplements with antioxidants.
  • Their blood pressure should be within normal limits.

排除标准

  • Individuals with a past of health problems that are likely to have a negative effect on the indicators to be tested.
  • Individuals with allergies.
  • People with liver and gastric tract problems (e.g. ulcers).

结局指标

主要结局

Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,2-diphenyl-1-picrylhydrazyl (DPPH) method.

Changes in uric acid following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.

Changes in lipid peroxidation following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.

Changes in bilirubin following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.

Changes in protein carbonyls following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,4-Dinitrophenylhydrazine (DNPH) method.

Changes in glutathione following 2 weeks of kefir consumption and placebo.

时间窗: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).

Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 5,5'-dithio-bis-(2-nitrobenzoic acid) (DTNB) method.

次要结局

  • Changes in hematocrit (HCT), Red blood cell Distribution Width (RDW), Plateletcrit (PCT) and Platelet Distribution Width (PDW) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in body composition (in kg) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in Mean Corpuscular Hemoglobin (MCH) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in resting heart rate following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • % Changes in body composition following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in waist-to-hip ratio following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in blood pressure following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in red blood count (RBC) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in hemoglobin (HGB) following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in body mass index following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)
  • Changes in Platelets, White Blood Cell Count (WBC), Neutrophils, Granulocytes, Monocytes following 2 weeks of kefir consumption and placebo.(2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athanasios Z. Jamurtas

Professor

University of Thessaly

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