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Completed

NCT Number: NCT05234645

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kefir consumption

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Anthropometry - 1

    Time frame: Baseline.

    Stature, waist and hip circumferences will be measured (all in cms).

  2. Anthropometry - 1

    Time frame: 8 weeks.

    Stature, waist and hip circumferences will be measured (all in cms).

  3. Anthropometry - 2

    Time frame: Baseline.

    Body mass will be measured.

  4. Anthropometry - 2

    Time frame: 8 weeks.

    Body mass will be measured.

  5. SF-IPAQ

    Time frame: Baseline.

    The SF-IPAQ questionnaire will be completed, to assess physical activity levels.

  6. A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).

    Time frame: Baseline

    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.

  7. A discontinuous, sub-maximal test, coupled with transcutaneous oxygen pressure (TcPO2).

    Time frame: 8 weeks.

    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. Blood pressure

    Time frame: Baseline.

    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).

  9. Blood pressure

    Time frame: 8 weeks.

    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).

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Registry information

Official study title

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

Acronym: PIMCO-KEFIR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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