Study of Personalized Dietary Intervention for the Control of Essential Hypertension

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02136264

Acronym

PCFADASH-HT

Enrollment

Registered

2014-05-12

Start date

2013-06-30

Completion date

2018-06-30

Last updated

2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

hypertension, dietary intervention, personalized nutrition, randomized controlled trial

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.

Interventions

OTHERPCFA interventional dietary counselling

OTHERconventional DASH diet counselling

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Other

Measure	Time frame
a reduction in antihypertensive treatment required i.e. reduced number of drugs required, or dosage of at least two drugs reduced by half	2 years

Countries

Nigeria

Contacts

Primary ContactNnamdi Nwosu, MB BS FWACP

dykenig@yahoo.com+2348037123803

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026