Oxidative StressNCT05715008
Kefir Consumption on Various Parameters in Adults Subjects
A study testing Kefir in people with Oxidative Stress, run by University of Thessaly.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Kefir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Kefir Consumption on Anthropometric, Physiological and Oxidative Stress Parameters in Adults Subjects
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).
Read the detailed description
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
- 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.
- Process of collecting results: At first visit of volunteers to the laboratory, anthropometric (height, weight, body fat percentage, waist and hip circumferences) and physiological measurements (heart rate, blood pressure) will be taken. Volunteers will also be given full instructions on how to record their diet. They will be given a form to record their diet for 3 days and will have to follow the same date before each next visit to the laboratory. Then they will have their second visit to the laboratory, where the first blood sampling will be taken, and they will be given the necessary amount of kefir or placebo (depending on the group to which they belong), which they will have to consume as a supplement for the following two weeks. At the end of the 2 weeks the volunteer will return to the laboratory where the second blood sampling will be performed. This will be followed by a 2-week washout period where participants will not receive any amount of kefir or placebo. At the end of this intervention, a fourth visit to the laboratory will take place, where the third blood sampling will be performed. Subsequently, the consumption of kefir or placebo will continue, except that participants who initially consumed kefir will receive the placebo and vice versa. The last blood sampling (fourth) will take place after two weeks.
- Measuring instruments: Dual-energy X-ray absorptiometry (DEXA) and a mechanical balance with a stadiometer will be used to determine the anthropometric characteristics. A Gulick tape measure will be used to measure the waist and hip circumferences. For the measurement of heart rate a polar type heart rate monitor will be used. A sphygmomanometer will be used to measure blood pressure. The dietary characteristics of their diet will be analysed using a Science Fit Diet 200A (ScienceFit, Greece). Parameters in the blood will be analyzed by Immunoenzymatic Analysis (ELISA) and visible-ultraviolet spectrophotometer.
- Blood parameters:
A portion of the blood will be utilized for a complete blood count analysis and parameters related to redox status (protein carbonyls, thiobarbituric acid reactive substances, reduced glutathione, oxidized glutathione, catalase, total antioxidant capacity, uric acid).
Statistical Analysis
A 2-way ANOVA with repeated measures will be performed. The statistical program SPSS 26 will be used.
- Conditions
- Oxidative Stress
- Being tested
- Kefir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KefirOther
Comparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects
PlaceboOther
Comparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects
| Study group | Role | What they receive |
|---|---|---|
| Kefir consumption | Experimental | Kefir consumption (300ml/day) for 2 weeks in a counterbalanced manner to 16 adult subjects Receives: Other: Kefir |
| Placebo (cow milk) | Placebo comparator | Placebo administration for 2 weeks in a counterbalanced manner to 16 adult subjects Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo.
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,2-diphenyl-1-picrylhydrazyl (DPPH) method.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Changes in glutathione following 2 weeks of kefir consumption and 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.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Changes in uric acid following 2 weeks of kefir consumption and placebo.
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Changes in bilirubin following 2 weeks of kefir consumption and placebo.
Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Changes in lipid peroxidation following 2 weeks of kefir consumption and placebo.
Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Changes in protein carbonyls following 2 weeks of kefir consumption and placebo.
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using 2,4-Dinitrophenylhydrazine (DNPH) method.
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Secondary outcomes (12)
Changes in body composition (in kg) following 2 weeks of kefir consumption and placebo.
Body mass (in kg), body fat mass (in kg), lean mass (in kg)
Measured: 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.
Body fat mass percentage, lean mass percentage
Measured: 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.
Body mass (in kg) and height (in cm).
Measured: 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.
Measurement of waist and hip circumference to calculate waist-to-hip ratio.
Measured: 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.
Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest.
Measured: 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.
Resting heart rate (beats per minute) measurement after at least 5 minutes at rest.
Measured: 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.
RBC (million cells per microliter)
Measured: 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.
HGB (grams per deciliter)
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
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.
HCT (%), RDW (%), PCT (%), PDW (%)
Measured: 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.
MCV and MPV (fL)
Measured: 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.
MCH (pg)
Measured: 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.
Platelets, WBC, Neutrophils, Granulocytes and Monocytes (in thousand cells per microliter)
Measured: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start30 Jan 2023 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion20 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z Jamurtas, PhD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715008
- Sponsor's protocol ID
- UTH_Kefir
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kefir Consumption on Anthropometric, Physiological and Oxidative Stress Parameters in Adults Subjects
- ClinicalTrials.gov ID
- NCT05715008
- Acronym / sponsor ID
- UTH_Kefir
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 20 Jun 2023 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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
- 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.
- Process of collecting results: At first visit of volunteers to the laboratory, anthropometric (height, weight, body fat percentage, waist and hip circumferences) and physiological measurements (heart rate, blood pressure) will be taken. Volunteers will also be given full instructions on how to record their diet. They will be given a form to record their diet for 3 days and will have to follow the same date before each next visit to the laboratory. Then they will have their second visit to the laboratory, where the first blood sampling will be taken, and they will be given the necessary amount of kefir or placebo (depending on the group to which they belong), which they will have to consume as a supplement for the following two weeks. At the end of the 2 weeks the volunteer will return to the laboratory where the second blood sampling will be performed. This will be followed by a 2-week washout period where participants will not receive any amount of kefir or placebo. At the end of this intervention, a fourth visit to the laboratory will take place, where the third blood sampling will be performed. Subsequently, the consumption of kefir or placebo will continue, except that participants who initially consumed kefir will receive the placebo and vice versa. The last blood sampling (fourth) will take place after two weeks.
- Measuring instruments: Dual-energy X-ray absorptiometry (DEXA) and a mechanical balance with a stadiometer will be used to determine the anthropometric characteristics. A Gulick tape measure will be used to measure the waist and hip circumferences. For the measurement of heart rate a polar type heart rate monitor will be used. A sphygmomanometer will be used to measure blood pressure. The dietary characteristics of their diet will be analysed using a Science Fit Diet 200A (ScienceFit, Greece). Parameters in the blood will be analyzed by Immunoenzymatic Analysis (ELISA) and visible-ultraviolet spectrophotometer.
- Blood parameters:
A portion of the blood will be utilized for a complete blood count analysis and parameters related to redox status (protein carbonyls, thiobarbituric acid reactive substances, reduced glutathione, oxidized glutathione, catalase, total antioxidant capacity, uric acid).
Statistical Analysis
A 2-way ANOVA with repeated measures will be performed. The statistical program SPSS 26 will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kefir consumption | Experimental | Other: KefirKefir consumption (300ml/day) for 2 weeks in a counterbalanced manner to 16 adult subjects |
| Placebo (cow milk) | Placebo comparator | Other: PlaceboPlacebo administration for 2 weeks in a counterbalanced manner to 16 adult subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KefirComparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects | Other | Kefir consumption |
| PlaceboComparison of kefir and placebo consumption for 2 weeks on various parameters in healthy adult subjects | Other | Placebo (cow milk) |
Primary outcome
Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo.
Time frame: 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 glutathione following 2 weeks of kefir consumption and placebo.
Time frame: 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.
Changes in uric acid following 2 weeks of kefir consumption and placebo.
Time frame: 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 bilirubin following 2 weeks of kefir consumption and placebo.
Time frame: 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 lipid peroxidation following 2 weeks of kefir consumption and placebo.
Time frame: 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 protein carbonyls following 2 weeks of kefir consumption and placebo.
Time frame: 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.
12 secondary outcomes
Changes in body composition (in kg) following 2 weeks of kefir consumption and placebo.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z Jamurtas, PhD study director
University of Thessaly
Questions about this trial
What is this clinical trial studying?
A study testing Kefir in people with Oxidative Stress, run by University of Thessaly.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athanasios Z Jamurtas, PhD (2431047054 ext. +30, ajamurt@pe.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total antioxidant capacity following 2 weeks of kefir consumption and placebo. (time frame: 2 weeks (Before and after 2 weeks of kefir consumption and before and after 2 weeks of placebo).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.