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NCT Number: NCT06600347

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.

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Key information

Conditions

Cardiovascular Complication

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Farahnaz Ahmed Mohamed

Suez, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DASH diet

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

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

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Stress measurement

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Farahnaz A. Mohamed, PHD

CONTACT

[email protected]

+20 10 04240928

Sameh H. Samir, professor

CONTACT

[email protected]

+20 10 05292444

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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