Health BehaviorWGNCT06160258
Impact of Convenience on Whole Grain Consumption
A study testing Ready to Eat (RTE) and Dried in people with Health Behavior and Diet, Healthy, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Diet, Healthy, Diet Habit
- What is being tested?
- Ready to Eat (RTE) and Dried
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99202
About this study
Official title: 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.
Read the 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 the WSU Food Lab, 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. 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.
- Conditions
- Health Behavior, Diet, Healthy, Diet Habit
- Being tested
- Ready to Eat (RTE), Dried
- Keywords
- whole grains, convenience, ready-to-eat
- Medical subject headings
- Health Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Eat (RTE)Behavioural
Participants will be provided precooked and individually packaged whole grains in the ready-to-eat (RTE) condition for reheating and consumption at home.
DriedBehavioural
Participants will be provided with dried whole grains for home preparation and consumption
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Dried |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-week period
Secondary outcomes (1)
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.
Measured: 4-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start2 Feb 2024
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Lisa Grentz, Washington State University
- Investigators
- Martine Perrigue, PhD, RD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160258
- Sponsor's protocol ID
- 20358
- Acronym
- WG
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are not collaborating with other researchers, thus there is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Convenience on Consumption of Intact Novel Whole Grains: A Comparison Between Ready-to-Eat and Dried Conditions
- ClinicalTrials.gov ID
- NCT06160258
- Acronym / sponsor ID
- WG / 20358
- Conditions
- Health Behavior, Diet, Healthy, Diet Habit
- Keywords
- whole grains, convenience, ready-to-eat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the WSU Food Lab, 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. 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ready-to-Eat condition | Experimental | Behavioral: Ready to Eat (RTE)Participants will be provided precooked and individually packaged whole grains in the ready-to-eat condition for reheating and consumption at home. |
| Dried condition | Experimental | Behavioral: DriedParticipants will be provided with whole grains of barley, buckwheat, and quinoa in the dried, bulk condition for home cooking and consumption. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Ready-to-Eat condition |
| DriedParticipants will be provided with dried whole grains for home preparation and consumption | Behavioural | Dried condition |
Primary outcome
Determine the effect of convenience on intake of intact cooked whole grains over a 4-week period
Time frame: 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.
1 secondary outcome
Determine the effect of a dietary intervention on intake of whole grains over a 4-week period
Time frame: 4-week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. The investigators are not collaborating with other researchers, thus there is no plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Perrigue, PhD, RD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready to Eat (RTE) and Dried in people with Health Behavior and Diet, Healthy, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of convenience on intake of intact cooked whole grains over a 4-week period (time frame: 4-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.