Impact of Convenience on Whole Grain Consumption (WG)

Impact of Convenience on Consumption of Intact Novel Whole Grains: A Comparison Between Ready-to-Eat and Dried Conditions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Behavior; Diet, Healthy; Diet Habit
• Intervention / Treatment: Behavioral: Ready to Eat (RTE); Behavioral: Dried

Detailed Description

The investigators will evaluate the effects of convenience on intake of intact whole grains. Forty-two participants (19 years or older) will be randomized to receive intact whole grains of barley, buckwheat, and quinoa in either a convenient ready-to-eat (RTE) form or a bulk (DRIED) form. Enrollment in the study will continue until 42 participants have completed the study. Recruitment will include posters, word-of-mouth, and online newsletters. Interested individuals will complete an online survey to determine initial eligibility. Eligible participants will be contacted by study staff and invited to an in-person orientation session. At the in-person visit, participant eligibility will be verified. Eligible participants will review and sign the informed consent form. Using standard clinical protocols, trained research staff will collect baseline measurements of height and weight, randomize participants to either the RTE or DRIED condition, provide education on whole grains and how to prepare the study grains, and provide participants with a link to complete a questionnaire about eating habits. Lastly, participants will be sent home with the 7 days' worth of study grains. This visit will take up to 90 minutes to complete.

The intervention is a total of four weeks, during which participants will incorporate intact whole grains into their usual diet. Four weeks should be a sufficient to observe dietary changes. Daily during the study, participants will be prompted to complete a brief online survey to report the type and amount of study grains consumed over the course of the day.

Once per week during the intervention, participants will visit our laboratory, located in the Health Sciences Building on the WSU - Spokane Campus, for a 10-15-minute visit. During each visit, the investigators will provide one weeks' worth of study grains and review adherence to study protocols. At the end of the fourth week, participants will return to the laboratory for a final exit visit where study staff will measure participant weight and administer an exit survey and food frequency questionnaire. Our statistical power calculations indicate that forty-two participants included in this pilot study is sufficient for detecting an effect of whole grain intake between the two study conditions.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine Perrigue, PhD, RD; Phone Number: 509-368-6911; Email: martine.perrigue@wsu.edu
• Study Contact Backup: Name: Lisa Grentz, MS, RD; Phone Number: 509-368-6957; Email: lisa.grentz@wsu.edu

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Washington State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ready-to-Eat condition; 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); Participants will be provided precooked and individually packaged whole grains in the ready-to-eat (RTE) condition for reheating and consumption at home.
Experimental: Dried condition; Participants will be provided with whole grains of barley, buckwheat, and quinoa in the dried, bulk condition for home cooking and consumption.	Behavioral: Dried; Participants will be provided with dried whole grains for home preparation and consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of a dietary intervention on intake of whole grains over a 4-week period	Compare baseline whole grain ounce equivalents to endpoint ounce equivalents using DHQIII.	4-week period

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Martine Perrigue, PhD, RD, Washington State University

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: whole grains; convenience; ready-to-eat
• Other Study ID Numbers: 000913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators are not collaborating with other researchers, thus there is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No