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

Healthy Subject Clinical Trial

Official title:

Comparative Assessment of Food Frequency Questionnaires

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02610023
• Other study ID #: OSU 14222
• Secondary ID: NCI-2015-00069
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Other:
• Questionnaire Administration
Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Spectroscopy
Undergo resonance Raman spectroscopy

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFQ estimated carotenoid intake	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
Primary	Levels of carotenoids in plasma	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
Primary	CCAT ability to estimate carotenoid intake	CCAT carotenoid intake will be correlated with blood carotenoid profiles. Statistical analysis will be conducted using Stata version 11.	Up to 3 months