Clinical trial NCT02610023: Food Frequency Questionnaires in Estimating Food Nutrient Intake in Healthy Young Adults
Official title: Comparative Assessment of Food Frequency Questionnaires
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy Subject
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: FFQ estimated carotenoid intake
timeFrame: Up to 3 months
measure: Levels of carotenoids in plasma
timeFrame: Up to 3 months
measure: CCAT ability to estimate carotenoid intake
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Steven Clinton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: