The Ready-to-Eat Meals for Cardiovascular Health Study

NCT ID: NCT05472454

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2023-05-01

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.

Conditions

Diet; Hypertension; Cardiovascular Diseases; Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ready-to-eat meals

Pre-Post

Group Type: OTHER

Ready-to-eat meals

Intervention Type: OTHER

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

Interventions

Ready-to-eat meals

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: lead

Responsible Party

Pablo Monsivais

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Monsivais, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

Washington State University

Spokane, Washington, United States

Countries

United States

Other Identifiers

19288-001

Identifier Type: -

Identifier Source: org_study_id