- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610023
Food Frequency Questionnaires in Estimating Food Nutrient Intake in Healthy Young Adults
Comparative Assessment of Food Frequency Questionnaires
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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Correlative studies
Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT
Undergo resonance Raman spectroscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FFQ estimated carotenoid intake
Time Frame: Up to 3 months
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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.
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Up to 3 months
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Levels of carotenoids in plasma
Time Frame: Up to 3 months
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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.
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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.
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Up to 3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Steven Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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