- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06892444
Sweet Corn and Carotenoids
May 12, 2026 updated by: University of Florida
Effects of Sweet Corn Intake on Carotenoid Levels and Gastrointestinal Wellness
This study will assess the effect of daily yellow and white sweet corn intake on serum lutein and zeaxanthin concentrations.
Skin carotenoid levels using the Veggie Meter will be assessed, and gastrointestinal symptoms and changes in fecal microbiota during a 4-week intervention period will be monitored.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults ≥ 18 years of age
- Able to provide written consent in English
- Baseline Veggie Meter score of ≤ 300 (Scale from 0 to 850)
- Willing to adhere to study procedures
Exclusion Criteria:
- Baseline Veggie Meter score of >300
- Corn allergy
- Current use of laxatives or antidiarrheal medications
- Previously or currently being treated for intestinal disease, including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer
- Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)
- Current cancer treatment
- Current pregnancy
- Vegetarian diet
- Elite athletes or long-distance runners.
- Use of antibiotic drugs within 1 month of the screening visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yellow Sweet Corn
1.5 cups of yellow sweet corn daily
|
Participants will consume 1.5 cups daily of yellow or white canned sweet corn.
|
|
Sham Comparator: White Sweet Corn
1.5 cups of white sweet corn daily
|
1.5 cups daily of canned yellow sweet corn
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum concentration of lutein + zeaxanthin
Time Frame: 28 days
|
Sum of serum concentrations of lutein and zeaxanthin.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2025
Primary Completion (Actual)
May 11, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 21, 2025
First Submitted That Met QC Criteria
March 21, 2025
First Posted (Actual)
March 24, 2025
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB202500277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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