Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
|ClinicalTrials.gov Identifier: NCT03211767|
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : February 12, 2019
The primary objective of this trial is to assess the effect of consumption of aged garlic extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive individuals following 8 weeks of supplementation.
Additional secondary objectives are to assess the effects of aged garlic extract powder intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose, office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist and hip circumference.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Dietary Supplement: Aged garlic extract Dietary Supplement: Placebo||Not Applicable|
Forty hypertensive volunteers between 18 and 75 years will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, double-blind, randomized, placebo-controlled intervention study for 8 weeks per study period following obtainment of informed consent.
The 2 periods of treatment will include:
- Treatment period: One capsule twice a day, providing 600 mg each of aged garlic extract powder, for a total of 1200 mg/day of aged garlic extract powder.
- Control period: The control product will be an identical-looking placebo capsules containing cellulose, which is being used as a filler in the treatment capsules.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension|
|Actual Study Start Date :||October 12, 2017|
|Actual Primary Completion Date :||July 25, 2018|
|Actual Study Completion Date :||July 25, 2018|
Active Comparator: Aged garlic extract
2 capsules per day containing aged garlic extract
Dietary Supplement: Aged garlic extract
Each capsule contains 600mg of aged garlic extract powder
Placebo Comparator: Placebo
2 capsules per day without aged garlic extract
Dietary Supplement: Placebo
Each capsule contains cellulose as a filler.
- 24 hour ambulatory blood pressure [ Time Frame: 8 weeks ]
- Blood total cholesterol [ Time Frame: 8 weeks ]
- Blood low-density lipoprotein cholesterol [ Time Frame: 8 weeks ]
- Blood high-density lipoprotein cholesterol [ Time Frame: 8 weeks ]
- Blood triglycerides [ Time Frame: 8 weeks ]
- Office blood pressure [ Time Frame: 8 weeks ]
- Pulse wave velocity [ Time Frame: 8 weeks ]Measured by Mobil-O-Graph
- Augmentation index [ Time Frame: 8 weeks ]Measured by Mobil-O-Graph
- Body mass index [ Time Frame: 8 weeks ]
- Waist circumference [ Time Frame: 8 weeks ]
- Hip circumference [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211767
|Richardson Centre for Functional Foods and Nutraceuticals|
|Winnipeg, Manitoba, Canada, R3T 6C5|
|Principal Investigator:||Peter Jones, PhD||University of Manitoba|