University of Minnesota Food Science and Nutrition Building
Saint Paul, Minnesota, 55108, United States
NCT Number: NCT07773441
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint Paul, Minnesota, 55108, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IWG-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.
Other names: WW-Based Products
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.
Time frame: 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.
University of Minnesota
Other
The Effect of Regular Consumption of Intermediate Wheatgrass-Based Products on Measures of Gut Health
Acronym: IWG Gut Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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