Study of Personalized Dietary Intervention for the Control of Essential Hypertension

Study Overview
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Brief Summary
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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.

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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Other: PCFA interventional dietary counselling
* Other: conventional DASH diet counselling


Participation Criteria
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Eligibility Criteria
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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 pregnancy age less than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCFA interventional dietary counselling<br>personalized categorical food avoidance dietary counselling | Other: PCFA interventional dietary counselling<br> <br> |
| Sham Comparator: conventional DASH diet counselling<br>DASH = conventional dietary approach to stop hypertension | Other: conventional DASH diet counselling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of hypertension (normal blood pressure, no drugs required) |  | 2 years | 
| serious (disabling) adverse events attributable to hypertension or its drug treatment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, dietary intervention, personalized nutrition, randomized controlled trial