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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 25, 2018

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: 1. 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. 2. 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.

Interventions

  • Dietary Supplement: Aged garlic extract
    • Each capsule contains 600mg of aged garlic extract powder
  • Dietary Supplement: Placebo
    • Each capsule contains cellulose as a filler.

Arms, Groups and Cohorts

  • Active Comparator: Aged garlic extract
    • 2 capsules per day containing aged garlic extract
  • Placebo Comparator: Placebo
    • 2 capsules per day without aged garlic extract

Clinical Trial Outcome Measures

Primary Measures

  • 24 hour ambulatory blood pressure
    • Time Frame: 8 weeks

Secondary 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

Participating in This Clinical Trial

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 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. Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Collaborator
    • Wakunga of America Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Jones, PhD, Principal Investigator, University of Manitoba

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