- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06499194
Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension
July 6, 2024 updated by: Ola Abu hashima abd elwahab, Beni-Suef University
DASH diet can reduce hypertension and decrease health expenses
Study Overview
Detailed Description
Hypertension is a prevalent cardiovascular risk factor associated with adverse outcomes and obesity.
Egypt's prevalence is 26.3%, exceeding rates in the U.S. and sub-Saharan Africa.
Lifestyle interventions like the DASH diet effectively manage hypertension, offering a cost-effective alternative to pharmacological treatments.
This study aims to assess the effects of the DASH diet on blood pressure, BMI, waist circumference, and fasting blood glucose, as well as its cost-effectiveness compared to pharmacological treatments.
This open-label prospective controlled clinical trial was conducted in Esna Health Administration, Luxor Governorate.
The FMREC of Beni-Suef University approved the study, which included 364 hypertensive patients aged 30-60.
Exclusions were patients with severe comorbidities or those who declined participation.
Measurements included height, weight, BMI, blood pressure, and laboratory tests.
The intervention group received a DASH diet education program.
Outcomes measured were blood pressure, BMI, waist circumference, weight, and fasting blood glucose at baseline and post-intervention.
Our study demonstrates the significant benefits of the DASH diet in managing blood pressure, weight, and fasting blood glucose levels in the Egyptian population.
The DASH diet substantially reduced systolic and diastolic blood pressure, with a notable decrease in the number of antihypertensive medications needed.
Additionally, participants on the DASH diet experienced significant weight loss and reduced BMI and waist circumference compared to the control group.
The economic implications of the DASH diet are also promising, with a notable decrease in the total cost of therapy due to reduced medication costs.
Study Type
Interventional
Enrollment (Actual)
364
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
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-
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Banī Suwayf, Egypt, 621125
- Faculty of medicine
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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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- patients diagnosed with primary hypertension (all stages) in the family medicine units of Esna Health Administration, located in Luxor Governorate.
- Individuals between the ages of 30 and 60, of both male and female genders.
Exclusion Criteria:
• Patients with cancer and either hepatic failure or renal impairment.
- Patients diagnosed with diabetes, metabolic illness, or terminal organ failure.
- A patient with severe or malignant hypertension.
- Individuals who decline to partake in our research.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intervention group
Participants will taken a medical history review, anthropometric assessments, and waist circumference measurements.
Tests included hemoglobin levels, kidney and liver function tests, fasting blood glucose, and lipid profiles.
Baseline antihypertensive medications will be recorded in an Excel sheet and taken DASH diet .
|
The Dietary Approaches to Stop Hypertension (DASH) diets rich in fruits and vegetables and reduced in saturated fat can lower the risk for high blood pressure and assist with blood pressure control in hypertensive persons
|
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Placebo Comparator: control group
Participants will taken a medical history review, anthropometric assessments, and waist circumference measurements.
Tests included hemoglobin levels, kidney and liver function tests, fasting blood glucose, and lipid profiles.
Baseline antihypertensive medications will be recorded in an Excel sheet and without taken DASH diet .
|
The Dietary Approaches to Stop Hypertension (DASH) diets rich in fruits and vegetables and reduced in saturated fat can lower the risk for high blood pressure and assist with blood pressure control in hypertensive persons
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood pressure
Time Frame: 9 month
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patient on DASH diet showing decrease on blood pressure
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9 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.
- Abolfotouh MA, Soliman LA, Abolfotouh SM, Raafat M. Knowledge and Practice of PHC Physicians toward the Detection and Management of Hypertension and Other CVD Risk Factors in Egypt. Int J Hypertens. 2011;2011:983869. doi: 10.4061/2011/983869. Epub 2011 Aug 11.
- Akhlaghi M. Dietary Approaches to Stop Hypertension (DASH): potential mechanisms of action against risk factors of the metabolic syndrome. Nutr Res Rev. 2020 Jun;33(1):1-18. doi: 10.1017/S0954422419000155. Epub 2019 Jul 30.
- Al-Smair A, Saadeh O, Saadeh A, Al-Ali A. Renovascular Compression by the Diaphragmatic Crus: A Case Report. Cureus. 2022 Apr 10;14(4):e24004. doi: 10.7759/cureus.24004. eCollection 2022 Apr.
- Ancker OV, Wehland M, Bauer J, Infanger M, Grimm D. The Adverse Effect of Hypertension in the Treatment of Thyroid Cancer with Multi-Kinase Inhibitors. Int J Mol Sci. 2017 Mar 14;18(3):625. doi: 10.3390/ijms18030625.
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 (Actual)
January 1, 2023
Primary Completion (Actual)
October 29, 2023
Study Completion (Actual)
June 29, 2024
Study Registration Dates
First Submitted
July 6, 2024
First Submitted That Met QC Criteria
July 6, 2024
First Posted (Actual)
July 12, 2024
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 6, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DASH diet and hypertension
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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