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

NCT06600347 | Recruiting

• 1 other identifier: P.T.REC/012/004059
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Complication

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Stress measurement

  3 months

Study Arms (3)

DASH diet group

EXPERIMENTAL

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

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

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

Dietary Supplement: DASH diet; Other: Progressive muscle relaxation; Drug: Anti hypertensive drugs

Interventions

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.

DASH diet and progressive muscle relaxation group; DASH diet group

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.

DASH diet and progressive muscle relaxation group; Progressive muscle relaxation group

Anti hypertensive drugs DRUG

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

DASH diet and progressive muscle relaxation group; DASH diet group; Progressive muscle relaxation group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Farahnaz Ahmed Mohamed

Suez, Egypt

RECRUITING

MeSH Terms

Interventions

Dietary Approaches To Stop Hypertension; Autogenic Training; Antihypertensive Agents

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Hypnosis; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mohamed Awad, professor

  Cairo University

  STUDY DIRECTOR

• Heba Abdel Halim, PHD

  National Institute of Nutrition

  STUDY DIRECTOR

• Hala Emara, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Farahnaz A. Mohamed, PHD

CONTACT

+20 10 04240928; mogyfarah@hotmail.com

Sameh H. Samir, professor

CONTACT

+20 10 05292444; shssalama@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: June 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)