- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05358561
Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
An Evaluation of the Effect of Grain-Like Products on Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes, will be a pioneer in many subjects.
As a result of the study, the relationships between the changes in the investigated parameters and the possible changes in these parameters will be revealed. The results obtained suggest that foods rich in soluble fiber such as chia and flaxseed and foods produced with the possible synergetic effect of chia and flaxseed are used in healthy and safe products suitable for our consumption habits, and that these products are both protective and protective against the development of complications such as obesity and type 2 diabetes, cardiovascular diseases. The investigators think that it may also play a role in preventing its progress.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Özlem ÖZPAK AKKUŞ, PhD
- Número de teléfono: +905051397978
- Correo electrónico: dytozlemozpak@hotmail.com
Ubicaciones de estudio
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Mersin, Pavo, 33040
- Reclutamiento
- Özlem ÖZPAK AKKUŞ
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Contacto:
- Özlem ÖZPAK AKKUŞ
- Número de teléfono: 05051397978
- Correo electrónico: dytozlemozpak@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The study will be conducted with 14 volunteers
- Aged between 19 and years 64
- No acute or chronic disease
- Body Mass Index (BMI) of 18.5-24.9 kg/m2
- Beck Depression Scale of 8 or less.
Exclusion Criteria:
- Using prescription drugs and/or fiber supplements
- Pregnant or lactating women
- Consuming excessive alcohol (> 2 drinks/day)
- Women in menstrual period
- Having allergic reaction to chia or flaxseed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Nutritional analyzes applied to four cakes
The study is two-fold.
In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory.
Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced.
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Experimental: Flaxseed cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
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Experimental: Chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
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Experimental: Flaxseed and chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
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Experimental: Standart
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Flax Seed Cake and Blood Glucose Parameters
Periodo de tiempo: One day
|
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed cake.
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One day
|
|
Flax Seed Cake and Plasma Insulin Levels
Periodo de tiempo: One day
|
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed cake.
|
One day
|
|
Flax Seed Cake and Satiety Response Measurements
Periodo de tiempo: One day
|
Measurement of the satiety response seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed cake.
|
One day
|
|
Chia Cake and Blood Glucose Parameters
Periodo de tiempo: One day
|
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of chia cake.
|
One day
|
|
Chia Cake and Plasma Insulin Levels
Periodo de tiempo: One day
|
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of chia cake.
|
One day
|
|
Chia Cake and Satiety Response Measurements
Periodo de tiempo: One day
|
Measurement of the satiety response seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of chia cake.
|
One day
|
|
Flax Seed and Chia Cake and Blood Glucose Parameters
Periodo de tiempo: One day
|
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed and chia cake.
|
One day
|
|
Flax Seed and Chia Cake and Plasma Insulin Levels
Periodo de tiempo: One day
|
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed and chia cake.
|
One day
|
|
Flax Seed Cake and Satiety Response Measurements
Periodo de tiempo: One day
|
Measurement of the satiety response seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of flax seed and chia cake.
|
One day
|
|
Standart Cake and Blood Glucose Parameters
Periodo de tiempo: One day
|
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of standart cake.
|
One day
|
|
Standart Cake and Plasma Insulin Levels
Periodo de tiempo: One day
|
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of standart cake.
|
One day
|
|
Standart Cake and Satiety Response Measurements
Periodo de tiempo: One day
|
Measurement of the satiety response seven times (0. minute, 15. minute, 30.
minute, 60. minute, 90.
minute, 120.
minute, 180.
minute) within three hours after consumption of standart cake.
|
One day
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes
Periodo de tiempo: Five days
|
The study is two-fold.
In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory.
Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced.
|
Five days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Otros números de identificación del estudio
- ChiaFlaxseed
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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