Kefir Cholesterol Lowering Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Traditionally and Commercially Prepared Kefir on Cholesterol Levels in Adult Males With Borderline High Cholesterol Levels

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: Kefir


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial Kefir<br>Commercially produced kefir | Other: Kefir<br>* commercial versus traditional kefir<br>|
| Experimental: Traditional Kefir<br>Traditionally grown kefir | Other: Kefir<br>* commercial versus traditional kefir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Lipids following provision of each type of Kefir | Change in blood lipid panel (HDL, LDL, Total Cholesterol, Triglycerides) will be measured in blood samples. | 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high cholesterol, kefir