NCT02136264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

4.5 years

First QC Date

May 8, 2014

Last Update Submit

November 10, 2015

Conditions

Essential Hypertension

Keywords

hypertensiondietary interventionpersonalized nutritionrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other

    2 years

Secondary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

PCFA interventional dietary counselling

ACTIVE COMPARATOR

personalized categorical food avoidance dietary counselling

Other: PCFA interventional dietary counselling

conventional DASH diet counselling

SHAM COMPARATOR

DASH = conventional "dietary approach to stop hypertension"

Other: conventional DASH diet counselling

Interventions

PCFA interventional dietary counsellingOTHER
PCFA interventional dietary counselling
conventional DASH diet counsellingOTHER
conventional DASH diet counselling

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • disabling complications of hypertension
  • secondary cause of hypertension
  • pregnancy
  • age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiolive International Medical Research Organisation

Enugu, Enugu State, 400001, Nigeria

RECRUITING

MeSH Terms

Conditions

Essential HypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Chioli P Chijioke, MA MB BChir MD

    College of Medicine, University of Nigeria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nnamdi Nwosu, MB BS FWACP

CONTACT

+2348037123803dykenig@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor C.P. Chijioke

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

NG(1)