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

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
PCFA interventional dietary counselling
conventional DASH diet counselling
Sponsored by
University of Nigeria, Enugu Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, dietary intervention, personalized nutrition, randomized controlled trial

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chiolive International Medical Research OrganisationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

PCFA interventional dietary counselling

conventional DASH diet counselling

Arm Description

personalized categorical food avoidance dietary counselling

DASH = conventional "dietary approach to stop hypertension"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

resolution of hypertension (normal blood pressure, no drugs required)
serious (disabling) adverse events attributable to hypertension or its drug treatment

Full Information

First Posted
May 8, 2014
Last Updated
November 10, 2015
Sponsor
University of Nigeria, Enugu Campus
Collaborators
University of Glasgow, University Of Nigeria Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02136264
Brief Title
Study of Personalized Dietary Intervention for the Control of Essential Hypertension
Acronym
PCFADASH-HT
Official Title
Randomized Controlled Trial of a Personalized Dietary Intervention Approach for the Control of Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nigeria, Enugu Campus
Collaborators
University of Glasgow, University Of Nigeria Teaching Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
hypertension, dietary intervention, personalized nutrition, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCFA interventional dietary counselling
Arm Type
Active Comparator
Arm Description
personalized categorical food avoidance dietary counselling
Arm Title
conventional DASH diet counselling
Arm Type
Sham Comparator
Arm Description
DASH = conventional "dietary approach to stop hypertension"
Intervention Type
Other
Intervention Name(s)
PCFA interventional dietary counselling
Intervention Type
Other
Intervention Name(s)
conventional DASH diet counselling
Primary Outcome Measure Information:
Title
a statistically significant 12 mm Hg (or more) greater change of blood pressure in one group compared to the other
Time Frame
2 years
Secondary Outcome Measure Information:
Title
resolution of hypertension (normal blood pressure, no drugs required)
Time Frame
2 years
Title
serious (disabling) adverse events attributable to hypertension or its drug treatment
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: disabling complications of hypertension secondary cause of hypertension pregnancy age less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nnamdi Nwosu, MB BS FWACP
Phone
+2348037123803
Email
dykenig@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chioli P Chijioke, MA MB BChir MD
Organizational Affiliation
College of Medicine, University of Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiolive International Medical Research Organisation
City
Enugu
ZIP/Postal Code
400001
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bridget Nwokolo, BSc Nursing Science
Phone
+2348060281994
Email
bridgetnwokolocd2007@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nnamdi Nwosu, MB BS FWACP

12. IPD Sharing Statement

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Study of Personalized Dietary Intervention for the Control of Essential Hypertension

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