NCT03211767

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable hypertension

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

January 3, 2017

Last Update Submit

February 9, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 24 hour ambulatory blood pressure

    8 weeks

Secondary Outcomes (10)

  • Blood total cholesterol

    8 weeks

  • Blood low-density lipoprotein cholesterol

    8 weeks

  • Blood high-density lipoprotein cholesterol

    8 weeks

  • Blood triglycerides

    8 weeks

  • Office blood pressure

    8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Aged garlic extract

ACTIVE COMPARATOR

2 capsules per day containing aged garlic extract

Dietary Supplement: Aged garlic extract

Placebo

PLACEBO COMPARATOR

2 capsules per day without aged garlic extract

Dietary Supplement: Placebo

Interventions

Aged garlic extractDIETARY_SUPPLEMENT

Each capsule contains 600mg of aged garlic extract powder

Aged garlic extract
PlaceboDIETARY_SUPPLEMENT

Each capsule contains cellulose as a filler.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 6C5, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Peter Jones, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

July 7, 2017

Study Start

October 12, 2017

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

CA(1)