NCT06892444

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress60%
May 2025Dec 2026

First Submitted

Initial submission to the registry

March 21, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 22, 2026

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

March 21, 2025

Last Update Submit

January 21, 2026

Conditions

Carotenoids

Keywords

sweet cornluteinzeaxanthincarotenoid

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of lutein + zeaxanthin

    Sum of serum concentrations of lutein and zeaxanthin.

    28 days

Study Arms (2)

Yellow Sweet Corn

EXPERIMENTAL

1.5 cups of yellow sweet corn daily

Dietary Supplement: Yellow Sweet Corn

White Sweet Corn

SHAM COMPARATOR

1.5 cups of white sweet corn daily

Dietary Supplement: White Sweet Corn

Interventions

Yellow Sweet CornDIETARY_SUPPLEMENT

Participants will consume 1.5 cups daily of yellow or white canned sweet corn.

Yellow Sweet Corn
White Sweet CornDIETARY_SUPPLEMENT

1.5 cups daily of canned yellow sweet corn

White Sweet Corn

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age
  • Able to provide written consent in English
  • Baseline Veggie Meter score of ≤ 250 (Scale from 0 to 850)
  • Willing to adhere to study procedures

You may not qualify if:

  • Baseline Veggie Meter score of \>250
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 24, 2025

Study Start

May 14, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 22, 2026

Record last verified: 2025-05

Locations

US(1)