CarotenoidsNCT06892444
Sweet Corn and Carotenoids
A study testing Yellow Sweet Corn and White Sweet Corn in people with Carotenoids, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotenoids
- What is being tested?
- Yellow Sweet Corn and White Sweet Corn
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Current pregnancy
- Vegetarian diet
- Elite athletes or long-distance runners.
- Use of antibiotic drugs within 1 month of the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Carotenoids
- Being tested
- Yellow Sweet Corn, White Sweet Corn
- Keywords
- sweet corn, lutein, zeaxanthin, carotenoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow Sweet CornDietary supplement
Participants will consume 1.5 cups daily of yellow or white canned sweet corn.
White Sweet CornDietary supplement
1.5 cups daily of canned yellow sweet corn
| Study group | Role | What they receive |
|---|---|---|
| Yellow Sweet Corn | Experimental | 1.5 cups of yellow sweet corn daily Receives: Dietary Supplement: Yellow Sweet Corn |
| White Sweet Corn | Sham comparator | 1.5 cups of white sweet corn daily Receives: Dietary Supplement: White Sweet Corn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of lutein + zeaxanthin
Sum of serum concentrations of lutein and zeaxanthin.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 May 2025
- Primary completion11 May 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarotenoidsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892444
- Sponsor's protocol ID
- IRB202500277
- Status last verified
- May 2026
- First submitted
- 21 Mar 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sweet Corn Intake on Carotenoid Levels and Gastrointestinal Wellness
- ClinicalTrials.gov ID
- NCT06892444
- Acronym / sponsor ID
- IRB202500277
- Conditions
- Carotenoids
- Keywords
- sweet corn, lutein, zeaxanthin, carotenoid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yellow Sweet Corn | Experimental | Dietary Supplement: Yellow Sweet Corn1.5 cups of yellow sweet corn daily |
| White Sweet Corn | Sham comparator | Dietary Supplement: White Sweet Corn1.5 cups of white sweet corn daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yellow Sweet CornParticipants will consume 1.5 cups daily of yellow or white canned sweet corn. | Dietary supplement | Yellow Sweet Corn |
| White Sweet Corn1.5 cups daily of canned yellow sweet corn | Dietary supplement | White Sweet Corn |
Primary outcome
Serum concentration of lutein + zeaxanthin
Time frame: 28 days
Sum of serum concentrations of lutein and zeaxanthin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yellow Sweet Corn and White Sweet Corn in people with Carotenoids, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of lutein + zeaxanthin (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.