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

NCT05234645 | Completed

• 1 other identifier: ER5560941
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microcirculation; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (9)

• Anthropometry - 1

  Baseline.

• Anthropometry - 1

  8 weeks.

• Anthropometry - 2

  Baseline.

• Anthropometry - 2

  8 weeks.

• SF-IPAQ

  Baseline.

Study Arms (2)

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.

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.

Other: Kefir consumption

Interventions

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.

Older group; Younger group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All recruited participants were either 18-35 yrs. or 55-75 yrs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Location

Study Officials

• Markos Klonizakis, D.Phil

  Reader (Clinical Physiology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 10, 2022
• Study Start: April 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)