Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension - Full Text View

Purpose

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	Intervention
Hypertension	Dietary Supplement: Aged garlic extract Dietary Supplement: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension

Resource links provided by NLM:

Drug Information available for: Allium sativum extract

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

24 hour ambulatory blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	40
Anticipated Study Start Date:	July 2017
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Detailed Description:

Forty hypertensive volunteers between 40 and 70 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.

Eligibility


Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 any lipid-lowering medication at a stable dose of the medication for greater than or equal to 3 months; all other medications other than blood-pressure lowering medication(which is not permitted throughout the study period) 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.

Exclusion Criteria:

Systolic blood pressure > 160mmHg and/or diastolic blood pressure >100mmHg
Those currently on blood-pressure lowering medication
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 in the past 6 months.
Plan to consume any type of garlic preparation at any time during the study.
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 blood thinning medications, protease inhibitors or medications with psychotropic properties
Smokers
Exercising > 15 miles/wk or 4,000 kcal/wk

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211767

Contacts


Contact: Stephanie Jew, BSc	204-272-1549	stephanie.jew@umanitoba.ca

Locations


Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals	Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 6C5
Contact: Peter JH Jones, PhD 204-474-8883 peter.jones@umanitoba.ca

Sponsors and Collaborators

University of Manitoba

Wakunga of America Co. Ltd.

Purity Life Health Products LP

Investigators


Principal Investigator:	Peter Jones, PhD	University of Manitoba

More Information


Responsible Party:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT03211767 History of Changes
Other Study ID Numbers:	HS19581 (B2016:019)
Study First Received:	January 3, 2017
Last Updated:	July 5, 2017


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 11, 2017