Essential Hypertension | Study of Personalized Dietary Intervention for the Control of Essential Hypertension
Essential Hypertension research study
What is the primary objective of this study?
An ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). Hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (J Hypertension 2012; 30: e-suppl 1, poster 158). Study hypothesis: this dietary approach would improve the control of essential hypertension. A randomized controlled clinical trial is proposed to compare this dietary approach with conventional DASH-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. They will be comprehensively monitored (including gene expression studies) for two years. Outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.
Who is eligible to participate?
Inclusion Criteria: 1. average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk), regardless of whether on treatment 2. on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if additional risk) 3. on three or more antihypertensives, regardless of whether BP controlled 4. sufficiently literate to follow detailed dietary instructions 5. informed consent Exclusion Criteria: 1. disabling complications of hypertension 2. secondary cause of hypertension 3. pregnancy 4. age less than 18 years
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:PCFA interventional dietary counselling
Other:conventional DASH diet counselling
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PCFA interventional dietary counsellingpersonalized categorical food avoidance dietary counselling
conventional DASH diet counsellingDASH = conventional "dietary approach to stop hypertension"
Start Date: June 2013
Completed Date: June 2018
Primary Outcome: a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
Secondary Outcome: resolution of hypertension (normal blood pressure, no drugs required)
Study sponsors, principal investigator, and references
Principal Investigator: Chioli P Chijioke, MA MB BChir MD
Lead Sponsor: University of Nigeria, Enugu Campus
Collaborator: University of Glasgow