None listed
Conditions
Brief summary
There is evidence for a link between hypertension and gut dysbiosis, microbiotical profile and inflammation, and inflammation and cognition. We postulate Kyolic aged garlic extract to influence gut microbiota, and to restore gut dysbiosis in hypertensives. Our study will comprise a double-blind parallel randomised placebo-controlled trial of 3 months duration investigating the effect of Kyolic aged garlic extract on gut microbiota, inflammatory markers, and cognitive function in patients with high blood pressure.
Interventions
Our study will comprise a double-blind parallel randomised placebo-controlled trial of 12 weeks duration investigating the effect of Kyolic aged garlic extract on gut microbiota, inflammatory markers, and cognitive function in patients with high blood pressure. The active treatment group will be allocated to two daily capsules of aged garlic extract (1.2 g Kyolic Reserve, 1.2 mg S-allylcysteine).
Compliance will be assessed by return of trial capsules, as well as diary entries.
Sponsors
A/Prof Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria - Essential hypertension: Mean systolic SBP >=140 mm Hg or diastolic blood pressure >=90 mm Hg to be confirmed under trial conditions at the screening appointment (at screening mean DBP of >=88 / SBP >=135 mm Hg will be included) - Either not on blood pressure medication, or on established plan of blood pressure medication (one or more classes) for at least 2 months - The patient’s doctor is not planning to change current treatment during the 3 month trial - Able to give informed consent
Exclusion criteria
Exclusion criteria - Poor comprehension of written or spoken English - Current or previous antibiotic treatment within the last 2 months of study enrolment - Currently taking anti-inflammatory agents, glucocorticoids or other immune regulating prescription medication - Currently taking probiotics - Currently taking garlic supplements - History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis, or diagnosed malabsorption disorder - Planning surgery in the next 3-4 months - Unstable other medical conditions or serious illness, at the discretion of the GP, e.g. dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis, and pregnancy - Severe hypertension (mean sitting SBP>=180 mm Hg and DBP >=110 mm Hg) at enrolment or subsequent visits during the study. Patients with severe hypertension will be referred back to their doctor for further management
Outcome results
None listed