Kefir Cholesterol Lowering Pilot Study

Sponsor

University of Alberta (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04247139

Collaborator

(none)

Enrollment

Location

Arms

29.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Other: Kefir	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Masking Description:

Both types of kefir will be flavoured the same, and visually look the same.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 7, 2020

Actual Primary Completion Date :

Apr 25, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Commercial Kefir Commercially produced kefir	Other: Kefir commercial versus traditional kefir
Experimental: Traditional Kefir Traditionally grown kefir	Other: Kefir commercial versus traditional kefir

Arm

Intervention/Treatment

Experimental: Commercial Kefir

Commercially produced kefir

Other: Kefir

commercial versus traditional kefir

Experimental: Traditional Kefir

Traditionally grown kefir

Other: Kefir

commercial versus traditional kefir

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2E1

Sponsors and Collaborators

University of Alberta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT04247139

Other Study ID Numbers:

Pro00087964

First Posted:

Jan 29, 2020

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Alberta

high cholesterol, kefir

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Jul 18, 2022