Study of Personalized Dietary Intervention for the Control of Essential Hypertension (PCFADASH-HT)

University of Nigeria, Enugu Campus

Status: Unknown

Conditions: Essential Hypertension

Treatments: Other: conventional DASH diet counselling; Other: PCFA interventional dietary counselling

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02136264

PCFADASH-HT

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

PCFA interventional dietary counselling

Active Comparator group

Description:

personalized categorical food avoidance dietary counselling

Treatment:

Other: PCFA interventional dietary counselling

conventional DASH diet counselling

Sham Comparator group

Description:

DASH = conventional "dietary approach to stop hypertension"

Treatment:

Other: conventional DASH diet counselling