Food PreferencesFL75NCT01403857
Evaluating Liking, Acceptability and Health Benefits of Grain Products
A study testing Whole grain foods and Refined grains in people with Food Preferences, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- Whole grain foods and Refined grains
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2013
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-45 years of age
- male or female
- consumers of 1 or fewer whole grain products per day
Who cannot join
- Type I or II Diabetes or glucose intolerance
- Preference for whole grains
- Do not cook at home
- Pregnant or planning to be pregnant
- Smoking
- Chronic inflammatory bowel disease
Show all 12Show fewer
- colorectal cancer
- Celiac disease or gluten sensitivity
- Crohn's disease
- Regular use of colonics and/or laxatives
- body weight change of >3% in last 6 months
- use of antibiotics, appetite suppressants, mood altering medications, and regular tobacco use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Research Center
Davis, California, 95616
About this study
The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.
Read the detailed description
Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.
- Conditions
- Food Preferences
- Being tested
- Whole grain foods, Refined grains
- Keywords
- Acceptability, liking
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain foodsOther
Eight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.
Refined grainsOther
Eight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whole Grain | Experimental | Whole grain products as defined by the American Association of Cereal Chemists (AACC) given in a market basket that contains eight commonly used grain products over six weeks. Receives: Other: Whole grain foods |
| Refined Grains | Placebo comparator | Time control compared to experimental intervention. Receives: Other: Refined grains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the acceptability and liking of grain products
Sensory evaluation of grain products
Measured: 0, 6 weeks
Change in the gut microbiota and their fermentation products
To determine if gut microbiota change over the intervention and if those changes persist over the long term. Gut microbiota assessed using 16S methodology.
Measured: 0, 6 weeks
Secondary outcomes (2)
Change in gastrointestinal function
Change in gastrointestinal function assessed using a questionnaire and exhaled breath hydrogen (ppm).
Measured: 0, 6 weeks
Liking the taste of grain products
Implicit Attitude Tests assessed using a calculated D score using the method described by Greenwald et al.
Measured: 0, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food PreferencesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nancy Keim, PhD, Principal investigator, USDA, Western Human Nutrition Research CenterWilliam Horn, MS, Study director, USDA, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403857
- Sponsor's protocol ID
- WHNRC 235561-1
- Acronym
- FL75
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2011
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Greenwald AG, Nosek BA, Banaji MR. Understanding and using the implicit association test: I. An improved scoring algorithm. J Pers Soc Psychol. 2003 Aug;85(2):197-216. doi: 10.1037/0022-3514.85.2.197.
PubMed 12916565Cooper DN, Kable ME, Marco ML, De Leon A, Rust B, Baker JE, Horn W, Burnett D, Keim NL. The Effects of Moderate Whole Grain Consumption on Fasting Glucose and Lipids, Gastrointestinal Symptoms, and Microbiota. Nutrients. 2017 Feb 21;9(2):173. doi: 10.3390/nu9020173.
PubMed 28230784Cooper DN, Martin RJ, Keim NL. Does Whole Grain Consumption Alter Gut Microbiota and Satiety? Healthcare (Basel). 2015 May 29;3(2):364-92. doi: 10.3390/healthcare3020364.
PubMed 27417768De Leon A, Burnett DJ, Rust BM, Casperson SL, Horn WF, Keim NL. Liking and Acceptability of Whole Grains Increases with a 6-Week Exposure but Preferences for Foods Varying in Taste and Fat Content Are Not Altered: A Randomized Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(3):nzaa023. doi: 10.1093/cdn/nzaa023. eCollection 2020 Mar.
PubMed 32190809De Leon A, Burnett DJ, Rust B, Lyly M, Keim NL. Initial implicit association between whole grains and taste does not predict consumption of whole grains in low-whole grain consumers: a pilot randomized controlled trial. Front Nutr. 2024 Sep 30;11:1408256. doi: 10.3389/fnut.2024.1408256. eCollection 2024.
PubMed 39403397
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Liking, Acceptability and Health Benefits of Grain Products
- ClinicalTrials.gov ID
- NCT01403857
- Acronym / sponsor ID
- FL75 / WHNRC 235561-1
- Conditions
- Food Preferences
- Keywords
- Acceptability, liking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jul 2011 (estimated)
- 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.
The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.
Detailed description
Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Grain | Experimental | Other: Whole grain foodsWhole grain products as defined by the American Association of Cereal Chemists (AACC) given in a market basket that contains eight commonly used grain products over six weeks. |
| Refined Grains | Placebo comparator | Other: Refined grainsTime control compared to experimental intervention. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-45 years of age
- male or female
- consumers of 1 or fewer whole grain products per day
Key exclusion criteria (12 listed)
- Type I or II Diabetes or glucose intolerance
- Preference for whole grains
- Do not cook at home
- Pregnant or planning to be pregnant
- Smoking
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 |
|---|---|---|
| Whole grain foodsEight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks. | Other | Whole Grain |
| Refined grainsEight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks. | Other | Refined Grains |
Primary outcome
Change in the acceptability and liking of grain products
Time frame: 0, 6 weeks
Sensory evaluation of grain products
Change in the gut microbiota and their fermentation products
Time frame: 0, 6 weeks
To determine if gut microbiota change over the intervention and if those changes persist over the long term. Gut microbiota assessed using 16S methodology.
2 secondary outcomes
Change in gastrointestinal function
Time frame: 0, 6 weeks
Liking the taste of grain products
Time frame: 0, 6 weeks
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 12 Mar 2024.
- Background: PubMed 12916565Greenwald AG, Nosek BA, Banaji MR. Understanding and using the implicit association test: I. An improved scoring algorithm. J Pers Soc Psychol. 2003 Aug;85(2):197-216. doi: 10.1037/0022-3514.85.2.197.
- Results publication: PubMed 28230784Cooper DN, Kable ME, Marco ML, De Leon A, Rust B, Baker JE, Horn W, Burnett D, Keim NL. The Effects of Moderate Whole Grain Consumption on Fasting Glucose and Lipids, Gastrointestinal Symptoms, and Microbiota. Nutrients. 2017 Feb 21;9(2):173. doi: 10.3390/nu9020173.
- Results publication: PubMed 27417768Cooper DN, Martin RJ, Keim NL. Does Whole Grain Consumption Alter Gut Microbiota and Satiety? Healthcare (Basel). 2015 May 29;3(2):364-92. doi: 10.3390/healthcare3020364.
- Results publication: PubMed 32190809De Leon A, Burnett DJ, Rust BM, Casperson SL, Horn WF, Keim NL. Liking and Acceptability of Whole Grains Increases with a 6-Week Exposure but Preferences for Foods Varying in Taste and Fat Content Are Not Altered: A Randomized Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(3):nzaa023. doi: 10.1093/cdn/nzaa023. eCollection 2020 Mar.
- Derived from this study: PubMed 39403397De Leon A, Burnett DJ, Rust B, Lyly M, Keim NL. Initial implicit association between whole grains and taste does not predict consumption of whole grains in low-whole grain consumers: a pilot randomized controlled trial. Front Nutr. 2024 Sep 30;11:1408256. doi: 10.3389/fnut.2024.1408256. eCollection 2024.
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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.
Nancy Keim, PhD principal investigator
USDA, Western Human Nutrition Research Center
William Horn, MS study director
USDA, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain foods and Refined grains in people with Food Preferences, run by USDA, Western Human Nutrition Research Center 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 3 inclusion and 12 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 12 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Change in the acceptability and liking of grain products (time frame: 0, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01403857, which also lists 5 linked publications.
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 12 Mar 2024.