Back to resultsKefir Cholesterol Lowering Pilot Study
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Kefir
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring high cholesterol, kefir
Eligibility Criteria
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:
-
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Commercial Kefir
Traditional Kefir
Arm Description
Commercially produced kefir
Traditionally grown kefir
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04247139
First Posted
January 22, 2020
Last Updated
January 11, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT04247139
Brief Title
Kefir Cholesterol Lowering Pilot Study
Official Title
Effect of Traditionally and Commercially Prepared Kefir on Cholesterol Levels in Adult Males With Borderline High Cholesterol Levels
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
high cholesterol, kefir
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Both types of kefir will be flavoured the same, and visually look the same.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Commercial Kefir
Arm Type
Experimental
Arm Description
Commercially produced kefir
Arm Title
Traditional Kefir
Arm Type
Experimental
Arm Description
Traditionally grown kefir
Intervention Type
Other
Intervention Name(s)
Kefir
Intervention Description
commercial versus traditional kefir
Primary Outcome Measure Information:
Title
Change in Blood Lipids following provision of each type of Kefir
Description
Change in blood lipid panel (HDL, LDL, Total Cholesterol, Triglycerides) will be measured in blood samples.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fecal microbiota composition changes following the provision of each type Kefir
Description
16SrRNA-sequencing and whole metagenome sequencing will performed to determine gut microbial community changes
Time Frame
4 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male participants
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Kefir Cholesterol Lowering Pilot Study
We'll reach out to this number within 24 hrs