Kefir Cholesterol Lowering Pilot Study

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Kefir

• Registration Number: NCT04247139
• Lead Sponsor: University of Alberta

Brief Summary

High cholesterol (a type of fat in humans blood) may be one factor that can lead to heart disease. If people have higher cholesterol, it is possible that kefir (a food similar to yogurt) may help to control blood cholesterol levels.

Detailed Description

New research shows that kefir (which contains bacteria also known as microbes), similar to yogurt, may improve health by lowering cholesterol levels. Much of this research however, focuses on traditional types of kefir, which differ significantly from commercially prepared kefir with regards to the types of microbes in each kefir. Additionally, there is a lack of research looking at how commercial kefir compares to traditional kefir in its ability to improve health. This has led to the consumer being confused about the health benefits they believe they are receiving, such as reduced weight gain, and improved cholesterol levels, when they purchase and consume commercial kefir. The researchers have produced a commercially usable kefir that has the health benefits of traditional grain fermented kefir. This was accomplished with only a small subset of microbes present in the traditional kefir, leading to a much easier product to commercialize and produce. Thus, this study aims to look at whether kefir, produced in the researchers laboratory and commercially available kefir, given to males for in two separate months, results in any cholesterol lowering effects. Successful completion of this project could potentially result in the development of a new commercial kefir with health benefits that are supported by scientific research and testing. In addition, if positive results are seen, a larger study will be carried out to ensure that results of the current study are consistent for the Canadian population.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Study Start: 2020-07-07
• Primary Completion: 2022-04-25
• Study Completion: 2022-09-16
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

1. Males, aged 18-65y
2. Moderately hypercholesterolemic adults: LDL-C between 3.2 and 4.9 mM, but otherwise healthy
3. No history of CVD, type 2 diabetes, monogenic dyslipidemia or use of medications for hyperlipidemia (including statins).
4. No dairy allergy

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Kefir	Kefir	Traditionally grown kefir
Commercial Kefir	Kefir	Commercially produced kefir

Primary Outcome Measures

Name	Time	Method
Change in Blood Lipids following provision of each type of Kefir	4 weeks	Change in blood lipid panel (HDL, LDL, Total Cholesterol, Triglycerides) will be measured in blood samples.

Secondary Outcome Measures

Name	Time	Method
Fecal microbiota composition changes following the provision of each type Kefir	4 weeks	16SrRNA-sequencing and whole metagenome sequencing will performed to determine gut microbial community changes

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada