NCT06160258

Brief Summary

Intact whole grains (such as quinoa, buckwheat, and barley) contain all 3 parts of the kernel (bran, germ, and endosperm) compared to processed grains where the bran and germ layers have been removed. Intact whole grains have a higher nutritional value but are under consumed in the diet of most adults. In this proposed pilot study, 42 participants will be recruited to study the impact of convenience on intake of intact whole grains by comparing consumption of intact whole grains that are offered in a convenient pre-cooked ready-to-eat form compared to traditional bulk dried form that requires a more prolonged preparation and cooking time. The ready-to-eat meals will be processed using WSU microwave technologies to ensure food safety. All intact whole grains (ready-to-eat or dried) will be provided to participants, who will prepare and consume the grains at home over a period of 4 weeks. Type and volume of whole grain consumed will be monitored daily via REDCap survey, which will allow the investigators to see if adults are more likely to meet daily recommended intakes of whole grain servings when offered in a convenient form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

November 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

November 28, 2023

Last Update Submit

April 1, 2025

Conditions

Keywords

whole grainsconvenienceready-to-eat

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of convenience on intake of intact cooked whole grains over a 4-week period

    Participants in the ready-to-eat condition and dried condition will self report type of cooked whole grain and quantity of cooked whole grains consumed daily in REDCap. The investigators will compare total intake of whole grains between the ready-to-eat and dried conditions as reported on daily REDCap checklists.

    4-week period

Secondary Outcomes (1)

  • Determine the effect of a dietary intervention on intake of whole grains over a 4-week period

    4-week period

Study Arms (2)

Ready-to-Eat condition

EXPERIMENTAL

Participants will be provided precooked and individually packaged whole grains in the ready-to-eat condition for reheating and consumption at home.

Behavioral: Ready to Eat (RTE)

Dried condition

EXPERIMENTAL

Participants will be provided with whole grains of barley, buckwheat, and quinoa in the dried, bulk condition for home cooking and consumption.

Behavioral: Dried

Interventions

Participants will be provided precooked and individually packaged whole grains in the ready-to-eat (RTE) condition for reheating and consumption at home.

Ready-to-Eat condition
DriedBEHAVIORAL

Participants will be provided with dried whole grains for home preparation and consumption

Dried condition

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to communicate in written and spoken English
  • Not following a restricted diet
  • Involved in home food preparation
  • Daily access to working internet
  • Daily access to working microwave, stove, refrigerator, and freezer

You may not qualify if:

  • Dietary restrictions, including allergy/intolerances
  • Latex allergy
  • Following a diet to increase or decrease body weight
  • Taking medications that promote weight loss
  • Use of nicotine, marijuana, or illicit drugs
  • Pregnancy, planned pregnancy, or breastfeeding
  • Inability to comprehend the nature of the study instructions
  • No access to internet
  • Planning to leave the Spokane area during the study
  • Not fluent in the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Health BehaviorFeeding Behavior

Interventions

Fast FoodsDesiccation

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesChemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Martine Perrigue, PhD, RD

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study employs a two-arm, randomized parallel design. Individuals, ages 19+, will be randomly assigned to one of two 4-week intervention conditions in which they receive either precooked intact novel whole grains ("RTE" condition) or dried, bulk novel whole grains ("DRIED" condition) to consume at home.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 7, 2023

Study Start

February 2, 2024

Primary Completion

May 22, 2024

Study Completion

May 22, 2024

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

The investigators are not collaborating with other researchers, thus there is no plan to make IPD available.

Locations