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Active, not recruiting

NCT Number: NCT07773441

Intermediate Wheatgrass Products and 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Food Science and Nutrition Building

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermediate Wheatgrass-Based Products

Dietary Supplement

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

Whole Wheat-Based Products

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Gastrointestinal Symptom Scores

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

The Effect of Regular Consumption of Intermediate Wheatgrass-Based Products on Measures of Gut Health

Acronym: IWG Gut Health

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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