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- Klinische proef NCT02610023
Vragenlijsten over voedselfrequentie bij het schatten van de inname van voedselvoedingsstoffen bij gezonde jonge volwassenen
Vergelijkende beoordeling van vragenlijsten over voedselfrequentie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Participants will be recruited from the Ohio State University Campus, Wexner Medical Center Hospitals, and surrounding greater Columbus area.
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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. |
Correlative studies Complete the Willett FFQ, the Fred Hutchinson FFQ, and the CCAT Undergo resonance Raman spectroscopy |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
FFQ estimated carotenoid intake
Tijdsspanne: 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. |
Up to 3 months
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Levels of carotenoids in plasma
Tijdsspanne: 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. |
Up to 3 months
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CCAT ability to estimate carotenoid intake
Tijdsspanne: Up to 3 months
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CCAT carotenoid intake will be correlated with blood carotenoid profiles. Statistical analysis will be conducted using Stata version 11. |
Up to 3 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Steven Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OSU 14222
- NCI-2015-00069 (Register-ID: CTRP (Clinical Trial Reporting Program))
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