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

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.

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

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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