Gut HealthIWG Gut HealthNCT07773441
Intermediate Wheatgrass Products and Gut Health
A study testing Intermediate Wheatgrass-Based Products and Whole Wheat-Based Products in people with Gut Health and Gastrointestinal Symptoms, run by University of Minnesota at 1 site in United States.
Trial summary
This study will evaluate the effect of daily consumption of intermediate wheatgrass-based products on measures of gut health compared with whole wheat-based products in healthy adults with traditional western fiber intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Health, Gastrointestinal Symptoms, Gut Microbiome
- What is being tested?
- Intermediate Wheatgrass-Based Products and Whole Wheat-Based Products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- Regular access to a smartphone
- Willingness to consume bread products daily in accordance with study procedures
Who cannot join
- Antibiotic use within 3 months
- Underlying chronic gastrointestinal disease, including irritable bowel syndrome, inflammatory bowel disease, and celiac disease
- History of malabsorptive bariatric surgery or colectomy
- Use of medications known to influence the gut microbiome
- In the opinion of the investigator, unable to complete study procedures
- Children
Show all 11Show fewer
- Pregnant women
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Food Science and Nutrition Building
Saint Paul, Minnesota, 55108
About this study
Official title: The Effect of Regular Consumption of Intermediate Wheatgrass-Based Products on Measures of Gut Health
This study will evaluate the effect of daily consumption of intermediate wheatgrass-based products on measures of gut health compared with whole wheat-based products in healthy adults with traditional western fiber intake.
Participants will first complete screening, stool sample collection, and the Diet History Questionnaire III. Participants with dietary fiber intake greater than 12g/1000 calories per day will complete the study after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will enter a randomized crossover dietary intervention.
During the intervention, participants will consume intermediate wheatgrass-based products and whole wheat-based products in randomized order. Each intervention period will last 2 weeks and will be separated by a 2-week washout period. The primary outcome is change in Gut Microbiome Wellness Index. Gastrointestinal symptom scores will also be assessed.
Read the detailed description
Intermediate wheatgrass is a perennial grain that is high in protein, antioxidants, and fiber. This study is designed to evaluate whether regular consumption of intermediate wheatgrass-based products improves measures of gut health compared with whole wheat-based products in healthy adults consuming a traditional western fiber intake.
The study will enroll healthy adults who are willing to consume bread products daily and have regular access to a smartphone. Participants will complete a REDCap pre-screening questionnaire. Eligible participants will complete informed consent, the National Cancer Institute Diet History Questionnaire III, and baseline stool sample collection.
Participants with dietary fiber intake greater than 12g/1000 calories per day will complete participation after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will proceed to the randomized crossover dietary intervention.
Participants in the crossover intervention will complete two 2-week dietary intervention periods separated by a 2-week washout period. They will be randomized to consume either intermediate wheatgrass-based products first or whole wheat-based products first. During each intervention period, participants will consume two slices of bread and 1/2 cup of puffed cereal per day. No additional dietary instruction will be provided.
Gut health will be assessed using stool samples and the Gut Microbiome Wellness Index. Gastrointestinal symptoms and bowel movement patterns will be assessed using a modified Gastrointestinal Symptom Rating Scale questionnaire. Additional dietary intake information will be collected using diet recalls and a food logging smartphone application.
- Conditions
- Gut Health, Gastrointestinal Symptoms, Gut Microbiome, Dietary Fiber
- Being tested
- Intermediate Wheatgrass-Based Products, Whole Wheat-Based Products
- Keywords
- Intermediate wheatgrass, Whole wheat, Gut health, Gastrointestinal symptoms, Gut Microbiome Wellness Index (GMWI), Gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate Wheatgrass-Based ProductsDietary supplement
Also called IWG-Based Products
Participants will consume two slices of bread made from whole intermediate wheatgrass flour and 1/2 cup of puffed intermediate wheatgrass cereal per day for 2 weeks.
Whole Wheat-Based ProductsDietary supplement
Also called WW-Based Products
Participants will consume two slices of bread made from whole wheat flour and 1/2 cup of puffed whole wheat cereal per day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Wheatgrass Products First, Then Whole Wheat Products | Experimental | Participants randomized to this sequence will consume intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then whole wheat-based bread and puffed cereal daily for 2 weeks. Receives: Dietary Supplement: Intermediate Wheatgrass-Based Products; Dietary Supplement: Whole Wheat-Based Products |
| Whole Wheat Products First, Then Intermediate Wheatgrass Products | Active comparator | Participants randomized to this sequence will consume whole wheat-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks. Receives: Dietary Supplement: Intermediate Wheatgrass-Based Products; Dietary Supplement: Whole Wheat-Based Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiome Wellness Index
Change in Gut Microbiome Wellness Index will be assessed using stool sample-based microbiome analysis and compared after daily consumption of intermediate wheatgrass-based products versus whole wheat-based products.
Measured: Baseline through 6 weeks
Secondary outcomes (1)
Change in Gastrointestinal Symptom Scores
Change in gastrointestinal symptom scores will be assessed using a modified Gastrointestinal Symptom Rating Scale questionnaire during the study to compare gastrointestinal symptoms after intermediate wheatgrass-based product consumption and whole wheat-based product consumption.
Measured: Baseline through 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2024
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be screened and enrolled as healthy individuals. After completing baseline stool collection and the Diet History Questionnaire III, participants with dietary fiber intake greater than 12g/1000 calories per day will complete participation. Participants with dietary fiber intake of 12g/1000 calories per day or less will proceed to the randomized crossover dietary intervention. These participants will complete both the intermediate wheatgrass-based product intervention and the whole wheat-based product intervention, separated by a 2-week washout period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Levi Teigen, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773441
- Sponsor's protocol ID
- STUDY00022051
- Acronym
- IWG Gut Health
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regular Consumption of Intermediate Wheatgrass-Based Products on Measures of Gut Health
- ClinicalTrials.gov ID
- NCT07773441
- Acronym / sponsor ID
- IWG Gut Health / STUDY00022051
- Conditions
- Gut Health, Gastrointestinal Symptoms, Gut Microbiome, Dietary Fiber
- Keywords
- Intermediate wheatgrass, Whole wheat, Gut health, Gastrointestinal symptoms, Gut Microbiome Wellness Index (GMWI), Gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Aug 2026 (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.
This study will evaluate the effect of daily consumption of intermediate wheatgrass-based products on measures of gut health compared with whole wheat-based products in healthy adults with traditional western fiber intake.
Participants will first complete screening, stool sample collection, and the Diet History Questionnaire III. Participants with dietary fiber intake greater than 12g/1000 calories per day will complete the study after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will enter a randomized crossover dietary intervention.
During the intervention, participants will consume intermediate wheatgrass-based products and whole wheat-based products in randomized order. Each intervention period will last 2 weeks and will be separated by a 2-week washout period. The primary outcome is change in Gut Microbiome Wellness Index. Gastrointestinal symptom scores will also be assessed.
Detailed description
Intermediate wheatgrass is a perennial grain that is high in protein, antioxidants, and fiber. This study is designed to evaluate whether regular consumption of intermediate wheatgrass-based products improves measures of gut health compared with whole wheat-based products in healthy adults consuming a traditional western fiber intake.
The study will enroll healthy adults who are willing to consume bread products daily and have regular access to a smartphone. Participants will complete a REDCap pre-screening questionnaire. Eligible participants will complete informed consent, the National Cancer Institute Diet History Questionnaire III, and baseline stool sample collection.
Participants with dietary fiber intake greater than 12g/1000 calories per day will complete participation after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will proceed to the randomized crossover dietary intervention.
Participants in the crossover intervention will complete two 2-week dietary intervention periods separated by a 2-week washout period. They will be randomized to consume either intermediate wheatgrass-based products first or whole wheat-based products first. During each intervention period, participants will consume two slices of bread and 1/2 cup of puffed cereal per day. No additional dietary instruction will be provided.
Gut health will be assessed using stool samples and the Gut Microbiome Wellness Index. Gastrointestinal symptoms and bowel movement patterns will be assessed using a modified Gastrointestinal Symptom Rating Scale questionnaire. Additional dietary intake information will be collected using diet recalls and a food logging smartphone application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be screened and enrolled as healthy individuals. After completing baseline stool collection and the Diet History Questionnaire III, participants with dietary fiber intake greater than 12g/1000 calories per day will complete participation. Participants with dietary fiber intake of 12g/1000 calories per day or less will proceed to the randomized crossover dietary intervention. These participants will complete both the intermediate wheatgrass-based product intervention and the whole wheat-based product intervention, separated by a 2-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Intermediate Wheatgrass Products First, Then Whole Wheat Products | Experimental | Dietary Supplement: Intermediate Wheatgrass-Based Products, Dietary Supplement: Whole Wheat-Based ProductsParticipants randomized to this sequence will consume intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then whole wheat-based bread and puffed cereal daily for 2 weeks. |
| Whole Wheat Products First, Then Intermediate Wheatgrass Products | Active comparator | Dietary Supplement: Intermediate Wheatgrass-Based Products, Dietary Supplement: Whole Wheat-Based ProductsParticipants randomized to this sequence will consume whole wheat-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 18 years of age
- Regular access to a smartphone
- Willingness to consume bread products daily in accordance with study procedures
Key exclusion criteria (11 listed)
- Antibiotic use within 3 months
- Underlying chronic gastrointestinal disease, including irritable bowel syndrome, inflammatory bowel disease, and celiac disease
- History of malabsorptive bariatric surgery or colectomy
- Use of medications known to influence the gut microbiome
- In the opinion of the investigator, unable to complete study procedures
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 |
|---|---|---|
| Intermediate Wheatgrass-Based ProductsAlso: IWG-Based ProductsParticipants will consume two slices of bread made from whole intermediate wheatgrass flour and 1/2 cup of puffed intermediate wheatgrass cereal per day for 2 weeks. | Dietary supplement | Intermediate Wheatgrass Products First, Then Whole Wheat Products, Whole Wheat Products First, Then Intermediate Wheatgrass Products |
| Whole Wheat-Based ProductsAlso: WW-Based ProductsParticipants will consume two slices of bread made from whole wheat flour and 1/2 cup of puffed whole wheat cereal per day for 2 weeks. | Dietary supplement | Intermediate Wheatgrass Products First, Then Whole Wheat Products, Whole Wheat Products First, Then Intermediate Wheatgrass Products |
Primary outcome
Change in Gut Microbiome Wellness Index
Time frame: Baseline through 6 weeks
Change in Gut Microbiome Wellness Index will be assessed using stool sample-based microbiome analysis and compared after daily consumption of intermediate wheatgrass-based products versus whole wheat-based products.
1 secondary outcome
Change in Gastrointestinal Symptom Scores
Time frame: Baseline through 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 15 Sep 2026.
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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.
Levi Teigen, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermediate Wheatgrass-Based Products and Whole Wheat-Based Products in people with Gut Health and Gastrointestinal Symptoms, run by University of Minnesota 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 11 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 15 Sep 2026. 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?
Change in Gut Microbiome Wellness Index (time frame: Baseline through 6 weeks). 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 15 Sep 2026.