NCT05472454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

July 15, 2022

Last Update Submit

June 1, 2026

Conditions

Keywords

DASHDietary Approaches to Stop HypertensionMealsHigh Blood PressureHypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    To determine dietary patterns on blood pressure using an omron blood pressure monitor.

    through study completion, measured weekly for 5 weeks

Secondary Outcomes (1)

  • Body weight (kg)

    through study completion, measured weekly for 5 weeks

Study Arms (1)

Ready-to-eat meals

OTHER

Pre-Post

Other: Ready-to-eat meals

Interventions

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

Ready-to-eat meals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • years old or older
  • BMI 18.5-40.0 kg/m2
  • Daily access to working internet, microwave, refrigerator, and freezer
  • English fluency

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

Fast Foods

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Pablo Monsivais, PhD, MPH

    Washington State University

    PRINCIPAL INVESTIGATOR
  • Martine M Perrigue, PhD, RDN

    Washington State University

    PRINCIPAL INVESTIGATOR
  • Catherine Jarrett, PhD, RDN

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pre-post design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 25, 2022

Study Start

October 7, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations