Skip to main content
Clinical Trials/NCT02136264
NCT02136264
Unknown
Not Applicable

Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension

University of Nigeria, Enugu Campus1 site in 1 country50 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Essential Hypertension
Sponsor
University of Nigeria, Enugu Campus
Enrollment
50
Locations
1
Primary Endpoint
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Nigeria, Enugu Campus
Responsible Party
Principal Investigator
Principal Investigator

Dr C.P. Chijioke

Professor C.P. Chijioke

University of Nigeria, Enugu Campus

Eligibility Criteria

Inclusion Criteria

  • average blood pressure exceeds 160/100mm Hg (140/90 if additional vascular risk), regardless of whether on treatment
  • on one or two antihypertensive drugs AND average BP exceeds 140/90 (130/80 if additional risk)
  • on three or more antihypertensives, regardless of whether BP controlled
  • sufficiently literate to follow detailed dietary instructions
  • informed consent

Exclusion Criteria

  • disabling complications of hypertension
  • secondary cause of hypertension
  • age less than 18 years

Outcomes

Primary Outcomes

a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other

Time Frame: 2 years

Secondary Outcomes

  • serious (disabling) adverse events attributable to hypertension or its drug treatment(2 years)
  • resolution of hypertension (normal blood pressure, no drugs required)(2 years)

Study Sites (1)

Loading locations...

Similar Trials