This trial is active, not recruiting.

Condition healthy subject
Treatments questionnaire administration, laboratory biomarker analysis, spectroscopy
Sponsor Ohio State University Comprehensive Cancer Center
Start date January 2015
End date June 2018
Trial size 100 participants
Trial identifier NCT02610023, NCI-2015-00069, OSU 14222


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.
questionnaire administration
Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT
laboratory biomarker analysis
Correlative studies
Undergo resonance Raman spectroscopy

Primary Outcomes

FFQ estimated carotenoid intake
time frame: Up to 3 months
Levels of carotenoids in plasma
time frame: Up to 3 months
CCAT ability to estimate carotenoid intake
time frame: Up to 3 months

Eligibility Criteria

All participants from 20 years up to 50 years old.

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)

Additional Information

Official title Comparative Assessment of Food Frequency Questionnaires
Principal investigator Steven Clinton, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.