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

November 10, 2015 updated by: Dr C.P. Chijioke, University of Nigeria, Enugu Campus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Enugu, Nigeria, 400001
        • Recruiting
        • Chiolive International Medical Research Organisation
        • Contact:
        • Sub-Investigator:
          • Nnamdi Nwosu, MB BS FWACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PCFA interventional dietary counselling
personalized categorical food avoidance dietary counselling
Other: PCFA interventional dietary counselling
SHAM_COMPARATOR: conventional DASH diet counselling
DASH = conventional "dietary approach to stop hypertension"
Other: conventional DASH diet counselling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome 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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nigeria, Enugu Campus

Collaborators

University of Glasgow
University Of Nigeria Teaching Hospital

Investigators

  • Principal Investigator: Chioli P Chijioke, MA MB BChir MD, College of Medicine, University of Nigeria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (ESTIMATE)

May 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCFADASH-HT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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