Sweet Corn and Carotenoids | NCT06892444

Studies
Sweet Corn and Carotenoids

NCT06892444

Sponsor

University of Florida

Status

Active, not recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Carotenoids

Interventions

Yellow Sweet Corn
White Sweet Corn

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2025Actual

Primary Completion Date

May 11, 2026Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Yellow Sweet Corn	Dietary Supplement	Participants will consume 1.5 cups daily of yellow or white canned sweet corn.	Yellow Sweet Corn

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum concentration of lutein + zeaxanthin	Sum of serum concentrations of lutein and zeaxanthin.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32611	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided