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

February 2, 2024 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center

Comparative Assessment of Food Frequency Questionnaires

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Correlative studies
Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT
Undergo resonance Raman spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months
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.
Up to 3 months
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.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • OSU 14222
  • NCI-2015-00069 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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