HypertensionNCT03211767
Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
A study testing Aged garlic extract in people with Hypertension, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aged garlic extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2017to 25 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give written informed consent.
- Age: greater than or equal to 40 and less than or equal to 70 years.
- Systolic blood pressure140-160mmHg and/or diastolic blood pressure 90-100 mmHg
- LDL-C less than or equal to 4.9mmol/L
- Those on a stable dose of blood pressure lowering or lipid-lowering medication for greater than or equal to 3 months; if a participant chooses to stop taking blood pressure lowering medications, they will be required to have a minimum 3 month washout period prior to commencement of the study; all other medications medications will be permitted if they are on a stable dose before the start of the study
- Gender: Male and women who are not pregnant (determined by a negative urine pregnancy test at screening for women of childbearing potential) or lactating.
- Language: Participants must be able to read, write and speak English.
Who cannot join
- Systolic blood pressure > 160mmHg and/or diastolic blood pressure >100mmHg
- Those currently taking (or have taken within the last 3 months) lipid-lowering or blood pressure-lowering supplements (i.e., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc.)
- Patients with unstable or serious illness, for example, dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis.
- History of cancer, chronic illness, cardiovascular problems, liver and kidney disease (including chronic kidney disease (GFR < 60ml/min/1.732)), diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological/psychological disease, bleeding disorders, experienced platelet abnormalities, macrovascular target organ damage (including cerebrovascular disease, stroke, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, and peripheral artery disease)
- History of taking any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil) in the past 6 months. in the past 3 months. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)
- Plan to consume any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil. at any time during the study. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)
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- Have gained or lost greater than or equal to 10lbs in the previous 3 months, or plan to lose weight at any time during the study
- Plan to become pregnant during the study period.
- Women of childbearing potential not using effective contraception which include: Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
- Consumption of more than 2 alcoholic drinks/day, or > 14 alcoholic beverages a week, or history of alcoholism or drug dependence.
- History of allergy to garlic, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, hydroxypropylcellulose, or caramel coloring
- Any planned surgeries any time during the study
- Taking medications with psychotropic properties for less than 3 months, i.e., those taking medications with psychotropic properties, such as anti-depressants, anti-anxiety, etc., at a stable consistent dose for a minimum of 3 months are eligible for the study, as long as the medication is consumed at a stable, consistent dose throughout the study period
- Smokers
- Exercising > 15 miles/wk or 4,000 kcal/wk
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 6C5
About this study
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Aged garlic extract, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged garlic extractDietary supplement
Each capsule contains 600mg of aged garlic extract powder
PlaceboDietary supplement
Each capsule contains cellulose as a filler.
| Study group | Role | What they receive |
|---|---|---|
| Aged garlic extract | Active comparator | 2 capsules per day containing aged garlic extract Receives: Dietary Supplement: Aged garlic extract |
| Placebo | Placebo comparator | 2 capsules per day without aged garlic extract Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour ambulatory blood pressure
Measured: 8 weeks
Secondary outcomes (10)
Blood total cholesterol
Measured: 8 weeks
Blood low-density lipoprotein cholesterol
Measured: 8 weeks
Blood high-density lipoprotein cholesterol
Measured: 8 weeks
Blood triglycerides
Measured: 8 weeks
Office blood pressure
Measured: 8 weeks
Pulse wave velocity
Measured by Mobil-O-Graph
Measured: 8 weeks
Augmentation index
Measured by Mobil-O-Graph
Measured: 8 weeks
Body mass index
Measured: 8 weeks
Waist circumference
Measured: 8 weeks
Hip circumference
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start12 Oct 2017
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunga of America Co. Ltd., Purity Life Health Products LP
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211767
- Sponsor's protocol ID
- HS19581 (B2016:019)
- Status last verified
- Feb 2019
- First submitted
- 3 Jan 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
- ClinicalTrials.gov ID
- NCT03211767
- Acronym / sponsor ID
- HS19581 (B2016:019)
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Wakunga of America Co. Ltd., Purity Life Health Products LP
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aged garlic extract | Active comparator | Dietary Supplement: Aged garlic extract2 capsules per day containing aged garlic extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules per day without aged garlic extract |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to give written informed consent.
- Age: greater than or equal to 40 and less than or equal to 70 years.
- Systolic blood pressure140-160mmHg and/or diastolic blood pressure 90-100 mmHg
- LDL-C less than or equal to 4.9mmol/L
- Those on a stable dose of blood pressure lowering or lipid-lowering medication for greater than or equal to 3 months; if a participant chooses to stop taking blood pressure lowering medications, they will be required to have a minimum 3 month washout period prior to commencement of the study; all other medications medications will be permitted if they are on a stable dose before the start of the study
Key exclusion criteria (15 listed)
- Systolic blood pressure > 160mmHg and/or diastolic blood pressure >100mmHg
- Those currently taking (or have taken within the last 3 months) lipid-lowering or blood pressure-lowering supplements (i.e., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc.)
- Patients with unstable or serious illness, for example, dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis.
- History of cancer, chronic illness, cardiovascular problems, liver and kidney disease (including chronic kidney disease (GFR < 60ml/min/1.732)), diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological/psychological disease, bleeding disorders, experienced platelet abnormalities, macrovascular target organ damage (including cerebrovascular disease, stroke, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, and peripheral artery disease)
- History of taking any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil) in the past 6 months. in the past 3 months. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged garlic extractEach capsule contains 600mg of aged garlic extract powder | Dietary supplement | Aged garlic extract |
| PlaceboEach capsule contains cellulose as a filler. | Dietary supplement | Placebo |
Primary outcome
24 hour ambulatory blood pressure
Time frame: 8 weeks
10 secondary outcomes
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
Augmentation index
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Hip circumference
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Jones, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged garlic extract in people with Hypertension, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour ambulatory blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.