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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02610023
Collaborator
(none)
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89
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire Administration
  • Other: Laboratory Biomarker Analysis
  • Device: Spectroscopy

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Assessment of Food Frequency Questionnaires
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm 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.

Other: Questionnaire Administration
Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Spectroscopy
Undergo resonance Raman spectroscopy

Outcome Measures

Primary Outcome Measures

  1. FFQ estimated carotenoid intake [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 [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 [Up to 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02610023
Other Study ID Numbers:
  • OSU 14222
  • NCI-2015-00069
First Posted:
Nov 20, 2015
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021

Study Results

No Results Posted as of Oct 22, 2021