Hypertension,EssentialNCT06499194
Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension
A study testing DASH diet in people with Hypertension,Essential, run by Beni-Suef University at 1 site in Egypt.
Trial summary
DASH diet can reduce hypertension and decrease health expenses Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- DASH diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 29 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
DASH diet can reduce hypertension and decrease health expenses
Read the 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.
- Conditions
- Hypertension,Essential
- Being tested
- DASH diet
- Keywords
- DASH diet, hypertension, health expense
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 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 . Receives: Other: DASH diet |
| control group | Placebo comparator | 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 . Receives: Other: DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
patient on DASH diet showing decrease on blood pressure
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jan 2023
- Primary completion29 Oct 2023
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an Open-label parallel design prospective controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Abu hashima abd elwahab, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499194
- Sponsor's protocol ID
- DASH diet and hypertension
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21860783Akhlaghi 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.
PubMed 31358075Al-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.
PubMed 35547452Appel 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.
PubMed 9099655Ancker 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.
PubMed 28335429
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06499194
- Acronym / sponsor ID
- DASH diet and hypertension
- Conditions
- Hypertension,Essential
- Keywords
- DASH diet, hypertension, health expense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DASH diet can reduce hypertension and decrease health expenses
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an Open-label parallel design prospective controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: DASH dietParticipants 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 . |
| control group | Placebo comparator | Other: DASH dietParticipants 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 . |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- • Patients with cancer and either hepatic failure or renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietThe 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 | Other | control group, intervention group |
Primary outcome
blood pressure
Time frame: 9 month
patient on DASH diet showing decrease on blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 21860783Abolfotouh 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.
- Background: PubMed 31358075Akhlaghi 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.
- Background: PubMed 35547452Al-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.
- Background: PubMed 9099655Appel 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.
- Background: PubMed 28335429Ancker 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet in people with Hypertension,Essential, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499194, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.