Study of Personalized Dietary Intervention for the Control of Essential Hypertension

Not Applicable

• Conditions: Essential Hypertension
• Interventions: Other: PCFA interventional dietary counselling; Other: conventional DASH diet counselling

• Registration Number: NCT02136264
• Lead Sponsor: University of Nigeria, Enugu Campus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PCFA interventional dietary counselling	PCFA interventional dietary counselling	personalized categorical food avoidance dietary counselling
conventional DASH diet counselling	conventional DASH diet counselling	DASH = conventional "dietary approach to stop hypertension"

Primary Outcome Measures

Name	Time	Method
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chiolive International Medical Research Organisation; 🇳🇬 Enugu, Nigeria