Study of Personalized Dietary Intervention for the Control of Essential Hypertension

Essential Hypertension Clinical Trial

— PCFADASH-HT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02136264
• Other study ID #: PCFADASH-HT
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2014
• Last updated: November 10, 2015
• Start date: June 2013
• Est. completion date: June 2018

Study information

• Verified date: November 2015
• Source: University of Nigeria, Enugu Campus
• Contact: Nnamdi Nwosu, MB BS FWACP
• Phone: +2348037123803
• Email: dykenig[@]yahoo.com
• Is FDA regulated: No
• Health authority: Nigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Other:
• PCFA interventional dietary counselling

• conventional DASH diet counselling

Locations

Country	Name	City	State
Nigeria	Chiolive International Medical Research Organisation	Enugu

Sponsors (3)

Lead Sponsor	Collaborator
University of Nigeria, Enugu Campus	University of Glasgow, University Of Nigeria Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other		2 years	No
Secondary	resolution of hypertension (normal blood pressure, no drugs required)		2 years	No
Secondary	serious (disabling) adverse events attributable to hypertension or its drug treatment		2 years	Yes