Short Term Effects of Probiotics in the Human Micro-vascular Physiology

Endothelial Dysfunction Clinical Trial

— PIMCO-KEFIR  

Official title:

Short Term Effects of Probiotics in the Human Micro-vascular Physiology - Comparison Between Older and Younger Healthy, Sedentary Adults: a Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234645
• Other study ID #: ER5560941
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2022
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

All recruited participants were either 18-35 yrs. or 55-75 yrs. Exclusion Criteria: 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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Microcirculation

Intervention

Other:
• Kefir consumption
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.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline.
Primary	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.	8 weeks.
Secondary	Anthropometry - 1	Stature, waist and hip circumferences will be measured (all in cms).	Baseline.
Secondary	Anthropometry - 1	Stature, waist and hip circumferences will be measured (all in cms).	8 weeks.
Secondary	Anthropometry - 2	Body mass will be measured.	Baseline.
Secondary	Anthropometry - 2	Body mass will be measured.	8 weeks.
Secondary	SF-IPAQ	The SF-IPAQ questionnaire will be completed, to assess physical activity levels.	Baseline.
Secondary	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.	Baseline
Secondary	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.	8 weeks.
Secondary	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).	Baseline.
Secondary	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).	8 weeks.