MicrocirculationPIMCO-KEFIRNCT05234645
Short Term Effects of Probiotics in the Human Micro-vascular Physiology
A study testing Kefir consumption in people with Microcirculation and Endothelial Dysfunction, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation, Endothelial Dysfunction
- What is being tested?
- Kefir consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 31 Oct 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All recruited participants were either 18-35 yrs. or 55-75 yrs.
Who cannot join
- Pregnancy; chronic diseases with the potential to influence vascular function; smoking status; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); regular consumption of probiotic-containing products; any overt chronic diseases.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, Yorkshire, S10 2BP
About this study
Official title: Short Term Effects of Probiotics in the Human Micro-vascular Physiology - Comparison Between Older and Younger Healthy, Sedentary Adults: a Pilot Study.
While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is to explore the short-term efficacy of kefir consumption in improving endothelial function in older and younger healthy, sedentary adults.
- Conditions
- Microcirculation, Endothelial Dysfunction
- Being tested
- Kefir consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kefir consumptionOther
Following confirmation of eligibility and the provision of informed consent, recruited participants were provided with a 4-week supply of kefir (Live Kefir Company, Pontefract, UK) being instructed to consume 150ml of Kefir per day for the whole 4-week period. No break periods of kefir consumption were offered to any of the participants. In addition, they were instructed to not change their usual dietary habits and exercise routine for the study duration.
| Study group | Role | What they receive |
|---|---|---|
| Younger group | Experimental | Fifteen participants, between 18 and 35 years of age. Participants are not pregnant; are healthy and suffering from no chronic diseases with the potential to influence vascular function; non-smoker; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); and were not consuming regularly probiotic-containing products. Additionally, a medical questionnaire was completed to exclude anyone with overt chronic disease. Receives: Other: Kefir consumption |
| Older group | Experimental | Fourteen participants, between 55 and 75 years of age. Participants are not pregnant; are healthy and suffering from no chronic diseases with the potential to influence vascular function; non-smoker; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); and were not consuming regularly probiotic-containing products. Additionally, a medical questionnaire was completed to exclude anyone with overt chronic disease. Receives: Other: Kefir consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microcirculatory function
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
Measured: Baseline.
Microcirculatory function
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
Measured: 8 weeks.
Secondary outcomes (9)
Anthropometry - 1
Stature, waist and hip circumferences will be measured (all in cms).
Measured: Baseline.
Anthropometry - 1
Stature, waist and hip circumferences will be measured (all in cms).
Measured: 8 weeks.
Anthropometry - 2
Body mass will be measured.
Measured: Baseline.
Anthropometry - 2
Body mass will be measured.
Measured: 8 weeks.
SF-IPAQ
The SF-IPAQ questionnaire will be completed, to assess physical activity levels.
Measured: Baseline.
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
A discontinuous, sub-maximal test, involving four rounds of exercise will measure the participants' transcutaneous oxygen pressure (TcPO2).TcPO2 values will be measured and recorded by a sensor. Measurements will be taken, using a TINA TCM400 TcPO2 device (Radiometer, Copenhagen, Denmark). The electrode will be placed on the participants' back, below the right scapula. The testing protocol includes a total of 20 min on a cycle ergometer (Monark894E, Vansbro, Sweden) with a 2-min break after each 5 min of exercise. Participants will maintain a speed of 80 revolutions per minute, and after each 5-min period, an extra 0.2 kg of resistance will be added to the ergometer, with a 1 kg of starting resistance value. Participants will be encouraged to reach their maximum exertion limit before completing the assessment but could stop before the end of the test if they feel so.
Measured: Baseline
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
A discontinuous, sub-maximal test, involving four rounds of exercise will measure the participants' transcutaneous oxygen pressure (TcPO2).TcPO2 values will be measured and recorded by a sensor. Measurements will be taken, using a TINA TCM400 TcPO2 device (Radiometer, Copenhagen, Denmark). The electrode will be placed on the participants' back, below the right scapula. The testing protocol includes a total of 20 min on a cycle ergometer (Monark894E, Vansbro, Sweden) with a 2-min break after each 5 min of exercise. Participants will maintain a speed of 80 revolutions per minute, and after each 5-min period, an extra 0.2 kg of resistance will be added to the ergometer, with a 1 kg of starting resistance value. Participants will be encouraged to reach their maximum exertion limit before completing the assessment but could stop before the end of the test if they feel so.
Measured: 8 weeks.
Blood pressure
Diastolic and systolic blood pressure will be recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA).
Measured: Baseline.
Blood pressure
Diastolic and systolic blood pressure will be recorded from the left arm at 5-minute intervals throughout the protocol (Dinamap Dash 2500, GE Healthcare, USA).
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Apr 2019
- Primary completion30 Apr 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markos Klonizakis, D.Phil, Principal investigator, Reader (Clinical Physiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234645
- Sponsor's protocol ID
- ER5560941
- Acronym
- PIMCO-KEFIR
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Probiotics in the Human Micro-vascular Physiology - Comparison Between Older and Younger Healthy, Sedentary Adults: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05234645
- Acronym / sponsor ID
- PIMCO-KEFIR / ER5560941
- Conditions
- Microcirculation, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 10 Feb 2022 (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.
While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is to explore the short-term efficacy of kefir consumption in improving endothelial function in older and younger healthy, sedentary adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger group | Experimental | Other: Kefir consumptionFifteen participants, between 18 and 35 years of age. Participants are not pregnant; are healthy and suffering from no chronic diseases with the potential to influence vascular function; non-smoker; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); and were not consuming regularly probiotic-containing products. Additionally, a medical questionnaire was completed to exclude anyone with overt chronic disease. |
| Older group | Experimental | Other: Kefir consumptionFourteen participants, between 55 and 75 years of age. Participants are not pregnant; are healthy and suffering from no chronic diseases with the potential to influence vascular function; non-smoker; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); and were not consuming regularly probiotic-containing products. Additionally, a medical questionnaire was completed to exclude anyone with overt chronic disease. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All recruited participants were either 18-35 yrs. or 55-75 yrs.
Key exclusion criteria (1 listed)
- Pregnancy; chronic diseases with the potential to influence vascular function; smoking status; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); regular consumption of probiotic-containing products; any overt chronic diseases.
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 |
|---|---|---|
| Kefir consumptionFollowing confirmation of eligibility and the provision of informed consent, recruited participants were provided with a 4-week supply of kefir (Live Kefir Company, Pontefract, UK) being instructed to consume 150ml of Kefir per day for the whole 4-week period. No break periods of kefir consumption were offered to any of the participants. In addition, they were instructed to not change their usual dietary habits and exercise routine for the study duration. | Other | Older group, Younger group |
Primary outcome
Microcirculatory function
Time frame: Baseline.
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
Microcirculatory function
Time frame: 8 weeks.
Skin blood flow will be measured as cutaneous red blood cell flux using a Laser Doppler Flowmeter (LDF). Local thermal hyperaemia will be induced using a heating disc surrounding the probe. The probe will be attached to the skin using a double-sided adhesion sticker. Participants will be rested in a supine position in a temperature-controlled room with a constant ambient temperature of 24° C for 35 minutes. Baseline skin blood flow data will be recorded for 5 minutes with the local heating disc temperature set at 30° C. Following this, rapid local heating will be initiated to obtain maximal vasodilation and the temperature will be increased by 1° C every 10 seconds until 42° C was reached. This will then be maintained for 30 minutes following, which the test will be completed.
9 secondary outcomes
Anthropometry - 1
Time frame: Baseline.
Anthropometry - 1
Time frame: 8 weeks.
Anthropometry - 2
Time frame: Baseline.
Anthropometry - 2
Time frame: 8 weeks.
SF-IPAQ
Time frame: Baseline.
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
Time frame: Baseline
A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).
Time frame: 8 weeks.
Blood pressure
Time frame: Baseline.
Blood pressure
Time frame: 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Markos Klonizakis, D.Phil principal investigator
Reader (Clinical Physiology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kefir consumption in people with Microcirculation and Endothelial Dysfunction, run by Sheffield Hallam University at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcirculatory function (time frame: Baseline.). The study lists 2 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 10 Feb 2022.