NCT07773441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 14, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

Intermediate wheatgrassWhole wheatGut healthGastrointestinal symptomsGut Microbiome Wellness Index (GMWI)Gut microbiome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through 6 weeks

Secondary Outcomes (1)

  • Change in Gastrointestinal Symptom Scores

    Baseline through 6 weeks

Study Arms (2)

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.

Dietary Supplement: Intermediate Wheatgrass-Based ProductsDietary 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.

Dietary Supplement: Intermediate Wheatgrass-Based ProductsDietary Supplement: Whole Wheat-Based Products

Interventions

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.

Also known as: IWG-Based Products
Intermediate Wheatgrass Products First, Then Whole Wheat ProductsWhole Wheat Products First, Then Intermediate Wheatgrass Products
Whole Wheat-Based ProductsDIETARY_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.

Also known as: WW-Based Products
Intermediate Wheatgrass Products First, Then Whole Wheat ProductsWhole Wheat Products First, Then Intermediate Wheatgrass Products

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years of age
  • Regular access to a smartphone
  • Willingness to consume bread products daily in accordance with study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Food Science and Nutrition Building

Saint Paul, Minnesota, 55108, United States

Location

Study Officials

  • Levi Teigen, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

September 1, 2024

Primary Completion

August 31, 2026

Study Completion

August 31, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Locations