Cardiovascular ComplicationNCT06600347
Effect of DASH Diet and Progressive Muscle Relaxation on Cardiovascular Risks in Postmenopausal Women
A study testing DASH diet, Progressive muscle relaxation and Anti hypertensive drugs in people with Cardiovascular Complication, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of DASH diet and Progressive muscle relaxation on cardiovascular risks in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Complication
- What is being tested?
- DASH diet, Progressive muscle relaxation and Anti hypertensive drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to Dec 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant's ages will be ranged from 50- 60 years old.
- Their body mass index will be ranged from 30-35 kg/m2.
- All women are hypertensive at least one year postmenopause.
- Their scores in perceived stress scale will be ranged from 14-40.
Who cannot join
- Women with systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100mmHg.
- Women who have other known causes of hypertension, such as renal diseases.
- Women who are using sedatives or tranquilizer or antidepressant drugs.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate the effect of DASH diet and Progressive muscle relaxation on cardiovascular risks in postmenopausal women.
Read the detailed description
Cardiovascular disease is the leading cause of morbidity and mortality in men and women, but the incidence of cardiovascular disease related deaths is higher in women than men. Hypertension is one of the leading risk factors for cardiovascular disease. Aging in both men and women is characterized by increases in blood pressure (BP), but the age-related increases are more rapid in women particularly postmenopausal women than in men.
A variety of non-pharmacologic treatments to manage stress have been found effective in reducing blood pressure and the development of hypertension. The DASH eating pattern promotes blood pressure reduction by encouraging the consumption of foods that are low in saturated fat, total fat, cholesterol, and sodium and high in potassium, calcium, magnesium, fiber, and protein. In terms of actual food choices, the DASH eating pattern encourages whole grains, fat free or low-fat dairy products, fruits, vegetables, poultry, fish, and nuts. Foods that are limited include fatty meats, full-fat dairy products, tropical oils (e.g., coconut, palm, and palm kernel oils), and sweets and sugar sweetened beverages.
The mechanism by which relaxation techniques lower blood pressure is unclear. One theory suggests that they may help lower the stress and physiologic arousal produced by the autonomic nervous system, thereby reducing blood pressure. So this study is a trial to determine the effect of DASH diet and progressive muscle relaxation in reducing cardiovascular risks in postmenopausal women.
- Conditions
- Cardiovascular Complication
- Being tested
- DASH diet, Progressive muscle relaxation, Anti hypertensive drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietDietary supplement
The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.
Progressive muscle relaxationOther
The participants will be treated with progressive muscle relaxation for 30 minutes, 3 times/week for 3 months, in addition to antihypertensive drugs.
Anti hypertensive drugsDrug
All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician
| Study group | Role | What they receive |
|---|---|---|
| DASH diet group | Experimental | The participants will be treated with the DASH diet and antihypertensive drugs Receives: Dietary Supplement: DASH diet; Drug: Anti hypertensive drugs |
| Progressive muscle relaxation group | Experimental | The participants will be treated with progressive muscle relaxation and antihypertensive drugs Receives: Other: Progressive muscle relaxation; Drug: Anti hypertensive drugs |
| DASH diet and progressive muscle relaxation group | Experimental | The participants will be treated with DASH diet and progressive muscle relaxation in addition to antihypertensive drugs Receives: Dietary Supplement: DASH diet; Other: Progressive muscle relaxation; Drug: Anti hypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
A sphygmomanometer will be used to measure systolic blood pressure (mmHg) for all participants in all groups before and after the treatment program
Measured: 3 months
Diastolic blood pressure
A sphygmomanometer will be used to measure systolic blood pressure (mmHg) for all participants in all groups before and after the treatment program
Measured: 3 months
Low density lipoprotein
Blood analysis will be used to measure level of low-density lipoprotein (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is less than 100 mg/dl.
Measured: 3 months
High density lipoprotein
Blood analysis will be used to measure level of high-density lipoprotein (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is from 40 to more than 60 mg/dl.
Measured: 3 months
Triglyceride level
Blood analysis will be used to measure the level of triglycerides (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is less than 150 mg/dl.
Measured: 3 months
Total cholesterol level
Blood analysis will be used to measure level of total cholesterol (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is up to 200 mg/dl.
Measured: 3 months
Secondary outcomes (1)
Stress measurement
Perceived stress scale (PSS) will be used to assess the degree of stress for all participants in all groups before and after the treatment program.The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way.
Scoring: PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 items scale can be made from questions 2, 4, 5 and 10 of the PSS 10 items scale. The higher the total score, the higher the perceived stress level.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Jun 2024
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farahnaz Ahmed Mohamed, Cairo University
- Investigators
- Mohamed Awad, professor, Study director, Cairo UniversityHeba Abdel Halim, PHD, Study director, National Institute of NutritionHala Emara, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600347
- Sponsor's protocol ID
- P.T.REC/012/004059
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DASH Diet and Progressive Muscle Relaxation on Cardiovascular Risks in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06600347
- Acronym / sponsor ID
- P.T.REC/012/004059
- Conditions
- Cardiovascular Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 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.
This study will be conducted to investigate the effect of DASH diet and Progressive muscle relaxation on cardiovascular risks in postmenopausal women.
Detailed description
Cardiovascular disease is the leading cause of morbidity and mortality in men and women, but the incidence of cardiovascular disease related deaths is higher in women than men. Hypertension is one of the leading risk factors for cardiovascular disease. Aging in both men and women is characterized by increases in blood pressure (BP), but the age-related increases are more rapid in women particularly postmenopausal women than in men.
A variety of non-pharmacologic treatments to manage stress have been found effective in reducing blood pressure and the development of hypertension. The DASH eating pattern promotes blood pressure reduction by encouraging the consumption of foods that are low in saturated fat, total fat, cholesterol, and sodium and high in potassium, calcium, magnesium, fiber, and protein. In terms of actual food choices, the DASH eating pattern encourages whole grains, fat free or low-fat dairy products, fruits, vegetables, poultry, fish, and nuts. Foods that are limited include fatty meats, full-fat dairy products, tropical oils (e.g., coconut, palm, and palm kernel oils), and sweets and sugar sweetened beverages.
The mechanism by which relaxation techniques lower blood pressure is unclear. One theory suggests that they may help lower the stress and physiologic arousal produced by the autonomic nervous system, thereby reducing blood pressure. So this study is a trial to determine the effect of DASH diet and progressive muscle relaxation in reducing cardiovascular risks in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DASH diet group | Experimental | Dietary Supplement: DASH diet, Drug: Anti hypertensive drugsThe participants will be treated with the DASH diet and antihypertensive drugs |
| Progressive muscle relaxation group | Experimental | Other: Progressive muscle relaxation, Drug: Anti hypertensive drugsThe participants will be treated with progressive muscle relaxation and antihypertensive drugs |
| DASH diet and progressive muscle relaxation group | Experimental | Dietary Supplement: DASH diet, Other: Progressive muscle relaxation, Drug: Anti hypertensive drugsThe participants will be treated with DASH diet and progressive muscle relaxation in addition to antihypertensive drugs |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participant's ages will be ranged from 50- 60 years old.
- Their body mass index will be ranged from 30-35 kg/m2.
- All women are hypertensive at least one year postmenopause.
- Their scores in perceived stress scale will be ranged from 14-40.
Key exclusion criteria (3 listed)
- Women with systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100mmHg.
- Women who have other known causes of hypertension, such as renal diseases.
- Women who are using sedatives or tranquilizer or antidepressant drugs.
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 participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs. | Dietary supplement | DASH diet and progressive muscle relaxation group, DASH diet group |
| Progressive muscle relaxationThe participants will be treated with progressive muscle relaxation for 30 minutes, 3 times/week for 3 months, in addition to antihypertensive drugs. | Other | DASH diet and progressive muscle relaxation group, Progressive muscle relaxation group |
| Anti hypertensive drugsAll participants in all groups will be treated with antihypertensive drugs as prescribed from the physician | Drug | DASH diet and progressive muscle relaxation group, DASH diet group, Progressive muscle relaxation group |
Primary outcome
Systolic blood pressure
Time frame: 3 months
A sphygmomanometer will be used to measure systolic blood pressure (mmHg) for all participants in all groups before and after the treatment program
Diastolic blood pressure
Time frame: 3 months
A sphygmomanometer will be used to measure systolic blood pressure (mmHg) for all participants in all groups before and after the treatment program
Low density lipoprotein
Time frame: 3 months
Blood analysis will be used to measure level of low-density lipoprotein (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is less than 100 mg/dl.
High density lipoprotein
Time frame: 3 months
Blood analysis will be used to measure level of high-density lipoprotein (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is from 40 to more than 60 mg/dl.
Triglyceride level
Time frame: 3 months
Blood analysis will be used to measure the level of triglycerides (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is less than 150 mg/dl.
Total cholesterol level
Time frame: 3 months
Blood analysis will be used to measure level of total cholesterol (mg/dl) for all participants in all groups before and after the treatment program. Its normal value is up to 200 mg/dl.
1 secondary outcome
Stress measurement
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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.
Mohamed Awad, professor study director
Cairo University
Heba Abdel Halim, PHD study director
National Institute of Nutrition
Hala Emara, professor study chair
Cairo University
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, Progressive muscle relaxation and Anti hypertensive drugs in people with Cardiovascular Complication, run by Cairo 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farahnaz A. Mohamed, PHD (+20 10 04240928, mogyfarah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.