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

NCT ID: NCT02610023

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subject

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Questionnaire Administration

Intervention Type OTHER

Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Spectroscopy

Intervention Type DEVICE

Undergo resonance Raman spectroscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire Administration

Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Spectroscopy

Undergo resonance Raman spectroscopy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steven Clinton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Clinton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2015-00069

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU 14222

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fast Food Photo Study
NCT02267954 COMPLETED NA
Meals and Grazing Study
NCT02548026 COMPLETED NA
The Fruit and Vegetable Study
NCT00468156 COMPLETED NA
Fast Food Photo Study 2
NCT02452658 COMPLETED NA
Free-living Validation of the RFPM in Adolescents
NCT04148560 ACTIVE_NOT_RECRUITING NA