Effect of DASH Diet and Progressive Muscle Relaxation on Cardiovascular Risks in Postmenopausal Women

NCT ID: NCT06600347

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be conducted to investigate the effect of DASH diet and Progressive muscle relaxation on cardiovascular risks in postmenopausal women.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DASH diet group

The participants will be treated with the DASH diet and antihypertensive drugs

Group Type EXPERIMENTAL

DASH diet

Intervention Type DIETARY_SUPPLEMENT

The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.

Anti hypertensive drugs

Intervention Type DRUG

All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician

Progressive muscle relaxation group

The participants will be treated with progressive muscle relaxation and antihypertensive drugs

Group Type EXPERIMENTAL

Progressive muscle relaxation

Intervention Type OTHER

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 drugs

Intervention Type DRUG

All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician

DASH diet and progressive muscle relaxation group

The participants will be treated with DASH diet and progressive muscle relaxation in addition to antihypertensive drugs

Group Type EXPERIMENTAL

DASH diet

Intervention Type DIETARY_SUPPLEMENT

The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.

Progressive muscle relaxation

Intervention Type OTHER

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 drugs

Intervention Type DRUG

All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DASH diet

The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.

Intervention Type DIETARY_SUPPLEMENT

Progressive muscle relaxation

The participants will be treated with progressive muscle relaxation for 30 minutes, 3 times/week for 3 months, in addition to antihypertensive drugs.

Intervention Type OTHER

Anti hypertensive drugs

All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Farahnaz Ahmed Mohamed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed Awad, professor

Role: STUDY_DIRECTOR

Cairo University

Heba Abdel Halim, PHD

Role: STUDY_DIRECTOR

National Institute of Nutrition

Hala Emara, professor

Role: STUDY_CHAIR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Farahnaz Ahmed Mohamed

Suez, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Farahnaz A. Mohamed, PHD

Role: CONTACT

+20 10 04240928

Sameh H. Samir, professor

Role: CONTACT

+20 10 05292444

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/004059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Neurovascular Adaptations in Aging Women
NCT06520982 RECRUITING EARLY_PHASE1
Sympathetic Mechanisms in Obesity-Crossover Design
NCT05312892 RECRUITING PHASE1/PHASE2
Blood Brain Flow and Exercise
NCT02653638 COMPLETED EARLY_PHASE1
Pathophysiology of Orthostatic Intolerance
NCT00608725 ACTIVE_NOT_RECRUITING NA