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NCT Number: NCT02610023

Food Frequency Questionnaires in Estimating Food Nutrient Intake in Healthy Young Adults

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVES:

I. To examine the relationship between estimated intakes of dietary carotenoids using three different FFQ's and comparing them with estimated carotenoid intake from 3 day diet records and blood and skin measurements.

OUTLINE:

Participants complete the Willett FFQ, the Fred Hutchinson FFQ, and the newly developed Clinton Carotenoid Assessment Tool (CCAT), in random order over a 3 to 4-month period of time with 4-6 weeks between each visit. Prior to each visit, participants also complete a 3-day diet record, a daily sun exposure diary, and a 3-day activity record. Blood samples are collected for plasma carotenoid assessment and and skin carotenoid content is assessed using a resonance Raman spectroscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Questionnaire Administration

Other

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

laboratory biomarker analysis

Other

Correlative studies

Spectroscopy

Device

Undergo resonance Raman spectroscopy

Primary outcomes

  1. FFQ estimated carotenoid intake

    Time frame: Up to 3 months

    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.

  2. Levels of carotenoids in plasma

    Time frame: Up to 3 months

    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.

  3. CCAT ability to estimate carotenoid intake

    Time frame: Up to 3 months

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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Comparative Assessment of Food Frequency Questionnaires

Important dates

Study start
2015
Primary completion
2015
Study completion
2026
First posted
Nov 20, 2015
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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