NCT04247139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 22, 2020

Last Update Submit

September 11, 2024

Conditions

Hypercholesterolemia

Keywords

high cholesterol, kefir

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fecal microbiota composition changes following the provision of each type Kefir

    4 weeks

Study Arms (2)

Commercial Kefir

EXPERIMENTAL

Commercially produced kefir

Other: Kefir

Traditional Kefir

EXPERIMENTAL

Traditionally grown kefir

Other: Kefir

Interventions

KefirOTHER

commercial versus traditional kefir

Commercial KefirTraditional Kefir

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale participants
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Kefir

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fermented BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaCultured Milk ProductsMilkFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both types of kefir will be flavoured the same, and visually look the same.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 29, 2020

Study Start

July 7, 2020

Primary Completion

April 25, 2022

Study Completion

September 16, 2022

Last Updated

September 19, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)