NCT02610023

Brief Summary

Fruits and vegetables are an important source of many different phytochemicals that may affect health and accurate dietary assessement tools to quantitate dietary intake are essential. This study will evaluate the correlation of dietary carotenoid intake estimated from two common and one novel food frequency questionnaire (FFQ) with estimated carotenoid intake from 3 day diet records as well as measured blood and skin concentrations of carotenoids. This study will be conducted in healthy adults. These tools may be effective in estimating the level of these compounds in an average diet.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2015

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress98%
Jan 2015Aug 2026

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
10.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 18, 2015

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • FFQ estimated carotenoid intake

    The relationship between the carotenoid values from the FFQ, both the unadjusted and the energy-adjusted estimates, and averages of the 3-day diet records will be estimated using the Pearson correlation coefficients. Statistical analysis will be conducted using Stata version 11.

    Up to 3 months

  • Levels of carotenoids in plasma

    Pearson correlations will be used to compare plasma levels of individual carotenoids with their respective dietary intake after adjustment for total energy, plasma cholesterol, plasma triglycerides, and BMI. Statistical analysis will be conducted using Stata version 11.

    Up to 3 months

  • CCAT ability to estimate carotenoid intake

    CCAT carotenoid intake will be correlated with blood carotenoid profiles. Statistical analysis will be conducted using Stata version 11.

    Up to 3 months

Study Arms (1)

Observational (Willett FFQ, Fred Hutchinson FFQ, CCAT)

After consenting to participate in this study, participants will visit the Clinical Research Center (CRC) on 3 occasions. One of the three FFQ's will be completed at each visit and there will be 4 to 6 weeks between visits. Participants will also complete a blood draw and assessment of skin carotenoids at this CRC visit. Prior to each visit, participants will complete a 3-day diet record, a daily sun exposure diary, and a 3-day activity record.

Other: Questionnaire AdministrationOther: Laboratory Biomarker AnalysisDevice: Spectroscopy

Interventions

Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT

Observational (Willett FFQ, Fred Hutchinson FFQ, CCAT)

Correlative studies

Observational (Willett FFQ, Fred Hutchinson FFQ, CCAT)

Undergo resonance Raman spectroscopy

Observational (Willett FFQ, Fred Hutchinson FFQ, CCAT)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the Ohio State University Campus, Wexner Medical Center Hospitals, and surrounding greater Columbus area.

You may qualify if:

  • Be literate and able to understand English
  • Have a body mass index (BMI) between 18.5 and 30 kg/m\^2; this represents the lowest end of the healthy BMI range and the upper limit of the overweight BMI range for our target age range
  • Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
  • Not currently be taking any vitamins, minerals, or dietary supplements (or agree to discontinue use for the duration of the study) and agree to consume a standardized daily multivitamin for the remainder of the study (CVS One Daily)
  • Voluntarily agree to participate and sign an informed consent document
  • Agree to three separate blood draws
  • Agree to three separate spectroscopy scans to assess skin carotenoid levels
  • Agree to complete three separate 3-day diet records, three separate 3-day activity records, and one habitual physical activity questionnaire

You may not qualify if:

  • Have an active metabolic or digestive illness, including malabsorptive disorders, renal insufficiency, hepatic insufficiency, hyper- or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome
  • Have an active or a recent history of any condition that causes altered immunity, such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
  • Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Spectrum Analysis

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Steven Clinton, MD, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion (Estimated)

August 1, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations