Kefir Cholesterol Lowering Pilot Study

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247139
• Other study ID #: Pro00087964
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 16, 2022

Study information

• Verified date: January 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 16, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Kefir
commercial versus traditional kefir

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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