Clinical trial NCT02136264: Study of Personalized Dietary Intervention for the Control of Essential Hypertension
Official title: Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Keywords: hypertension
dietary intervention
personalized nutrition
randomized controlled trial
Lead sponsor: University of Nigeria, Enugu Campus
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University Of Nigeria Teaching Hospital
First posted: 2014-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
timeFrame: 2 years
Secondary outcomes:
measure: resolution of hypertension (normal blood pressure, no drugs required)
timeFrame: 2 years
measure: serious (disabling) adverse events attributable to hypertension or its drug treatment
timeFrame: 2 years
Other outcomes:
measure: a reduction in antihypertensive treatment required i.e. reduced number of drugs required, or dosage of at least two drugs reduced by half
timeFrame: 2 years
Locations:
city: Enugu
country: Nigeria
facility: Chiolive International Medical Research Organisation
Study officials:
affiliation: College of Medicine, University of Nigeria
name: Chioli P Chijioke, MA MB BChir MD
role: PRINCIPAL_INVESTIGATOR
References: