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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Complication
• Intervention / Treatment: Dietary supplement: DASH diet; Drug: Anti hypertensive drugs; Other: Progressive muscle relaxation

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Farahnaz A. Mohamed, PHD; Phone Number: +20 10 04240928; Email: mogyfarah@hotmail.com
• Study Contact Backup: Name: Sameh H. Samir, professor; Phone Number: +20 10 05292444; Email: shssalama@hotmail.com

Study Locations

• Egypt
  • Suez, Egypt
    • Recruiting
    • Farahnaz Ahmed Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DASH diet group; The participants will be treated with the DASH diet and antihypertensive drugs	Dietary supplement: DASH diet; The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.; Drug: Anti hypertensive drugs; All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician
Experimental: Progressive muscle relaxation group; The participants will be treated with progressive muscle relaxation and antihypertensive drugs	Drug: Anti hypertensive drugs; All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician; Other: 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.
Experimental: DASH diet and progressive muscle relaxation group; The participants will be treated with DASH diet and progressive muscle relaxation in addition to antihypertensive drugs	Dietary supplement: DASH diet; The participants will be treated with the DASH diet (1600-1800 calories/ day) for three months, in addition to antihypertensive drugs.; Drug: Anti hypertensive drugs; All participants in all groups will be treated with antihypertensive drugs as prescribed from the physician; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hala Emara, professor, Cairo university; Study Director: Mohamed Awad, professor, Cairo university; Study Director: Heba Abdel Halim, PHD, National Institute of Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents
• Other Study ID Numbers: P.T.REC/012/004059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No