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

NCT ID: NCT05234645

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Microcirculation Endothelial Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Younger group

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.

Group Type EXPERIMENTAL

Kefir consumption

Intervention Type 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

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.

Group Type EXPERIMENTAL

Kefir consumption

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheffield Hallam University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markos Klonizakis, D.Phil

Role: PRINCIPAL_INVESTIGATOR

Reader (Clinical Physiology)

Locations

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Sheffield Hallam University

Sheffield, Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ER5560941

Identifier Type: -

Identifier Source: org_study_id

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