The Ready-to-Eat Meals for Cardiovascular Health Study

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Hypertension; Diet; Blood Pressure
• Interventions: Other: Ready-to-eat meals

• Registration Number: NCT05472454
• Lead Sponsor: Washington State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-25
• Study Start: 2022-10-07
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ready-to-eat meals	Ready-to-eat meals	Pre-Post

Primary Outcome Measures

Name	Time	Method
Blood pressure	through study completion, measured weekly for 5 weeks	To determine dietary patterns on blood pressure using an omron blood pressure monitor.

Secondary Outcome Measures

Name	Time	Method
Body weight (kg)	through study completion, measured weekly for 5 weeks	To determine dietary patterns on body weight (kg) using a Angel USA 400 Pound Physician Digital Scale.

Trial Locations

Locations (1)

Washington State University; 🇺🇸 Spokane, Washington, United States