Dietary Fiber, Gastrointestinal Symptoms, Gut Health, Gut Microbiome
Conditions
Keywords
Intermediate wheatgrass, Whole wheat, Gut health, Gastrointestinal symptoms, Gut Microbiome Wellness Index (GMWI), Gut microbiome
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTIntermediate Wheatgrass-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.
DIETARY_SUPPLEMENTWhole Wheat-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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than 18 years of age * Regular access to a smartphone * Willingness to consume bread products daily in accordance with study procedures
Exclusion criteria
* 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 * Pregnant women * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Non-English speakers * Individuals unable to read
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbiome Wellness Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Scores | Baseline through 6 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLevi Teigen, PhD
University of Minnesota
Outcome results
None listed