- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02610023
Cuestionarios de frecuencia alimentaria para estimar la ingesta de nutrientes alimentarios en adultos jóvenes sanos
Evaluación comparativa de los cuestionarios de frecuencia de alimentos
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Participants will be recruited from the Ohio State University Campus, Wexner Medical Center Hospitals, and surrounding greater Columbus area.
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
FFQ estimated carotenoid intake
Periodo de tiempo: Up to 3 months
|
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
Periodo de tiempo: 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
|
|
CCAT ability to estimate carotenoid intake
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Steven Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OSU 14222
- NCI-2015-00069 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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