The Ready-to-Eat Meals for Cardiovascular Health Study

Hypertension Clinical Trial

— REACH  

Official title:

The Ready-to-EAt Meals for Cardiovascular Health (REACH) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472454
• Other study ID #: 19288-001
• Status: Completed
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project explores the acceptability and health benefits of ready-to-eat (RTE) meals based on the Dietary Approaches to Stop Hypertension (DASH) eating plan. The researchers have developed 14 recipes following the DASH eating plan, which is recommended for the prevention of cardiovascular disease (CVD). The prepackaged meals will be processed using Washington State University (WSU) microwave technologies to ensure food safety. In this pilot study, a sample of 30 participants will be recruited by to study the impact of the DASH meals on blood pressure. All meals will be provided to participants, who will consume the meals daily over a period of 4 weeks. Daily and weekly monitoring of participants (blood pressure and weight) will allow us to gain a scientific understanding on the preventive power of healthy diets in lowering blood pressure and reducing CVD risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• 18 years old or older

• BMI 18.5-40.0 kg/m2

• Daily access to working internet, microwave, refrigerator, and freezer

• English fluency

Exclusion Criteria:

• Regular use of drugs that affect BP, including weight loss medications

• Diagnosed hypertension OR systolic BP >130 and/or diastolic BP >80

• Diagnosis of any hypotensive disorders OR systolic BP <100 and/or diastolic BP<65

• Dietary restrictions, including allergy/intolerances

• Presence or history of diabetes

• Previous cardiac event, congestive heart failure, or angina

• Weight loss or gain>15lb in previous 3 months

• Following a diet to increase or decrease body weight

• Cancer diagnosis or treatment in past 2 years

• =14 alcoholic drinks/week for men; = 7 alcoholic drinks/week for women

• Use of nicotine, marijuana, or illicit drugs

• Pregnancy, planned pregnancy, or breastfeeding

• Inability to comprehend the nature of the study or instructions

• No access to the internet

• Planning to leave the Spokane area during the study

• Not fluent in the English language

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Diet
• Hypertension

Intervention

Other:
• Ready-to-eat meals
Participant group to consume ready-to-eat meals in accordance with the DASH diet for a period of 4 weeks.

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	To determine dietary patterns on blood pressure using an omron blood pressure monitor.	through study completion, measured weekly for 5 weeks
Secondary	Body weight (kg)	To determine dietary patterns on body weight (kg) using a Angel USA 400 Pound Physician Digital Scale.	through study completion, measured weekly for 5 weeks