Acute Effect of Cheeses With Different Energy Content on Appetite (STABLE)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants will arrive at the laboratory after an overnight fast (at least from 10:00 pm) with the use of the least strenuously transportation possible (no bicycling or long distance walk). In addition, the preceding two days (48h) before each of the study days; no intensive physical activity or consumption of alcohol is allowed in order to obtain standardization of the participants.
Once settled into an individual feeding cubicle, visual analogue scales (VAS) will be completed for the measurement of fasting appetite levels. A standardized fixed breakfast meal (providing approximately 20% of total estimated energy need) consisting of 80 g. cheese with bread, orange juice and a cup (125 mL) of coffee/the/water (milk is not allowed). The amounts of bread (70.5 g.) and juice (132 g.) are calculated with Babybel original as reference, and these amounts for bread and juice are kept constant regardless of the cheese provided. The cheese will be served blinded together with the bread, and the brand of cheese will not be mentioned for the participants. Participants will be asked to consume this breakfast within 15 minutes and the exact meal duration (in minutes) will be noted after completing the meal in order to examine the eating rate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal and the study products after completing the meal. VAS will be used to measure subjective appetite sensations for the following hours. Three hours following serving of the breakfast meal, participants will be provided with a homogeneous single item ad libitum lunch meal. The meal is a homogeneous dish of spaghetti bolognese providing a total of 8 MJ and the participants are instructed to eat until they are comfortably full. The energy composition of the meal is 15 E% protein, 30 E% fat and 55 E% carbohydrate. VAS will be used to measure subjective appetite sensations during the post-meal period as well as the pleasantness of the meal after completing the meal. The meal duration (in minutes) will be noted after completing the meal. The ad libitum meal ends the study day, and the participant will be free to leave afterwards.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Copenhagen, Dinamarca, 1958
- University of Copenhagen
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants who have provided written informed consent
- Healthy men and women
- Ages between 18 and 60 years
- BMI between 20.0-31.9 kg/m2
- Regular breakfast eaters (eating breakfast ≥ 4 times a week)
- Regular menstrual periods (women only)
Exclusion Criteria:
- Participants not able to comply with the study protocol, including consumption of the specific study foods
- Significant health problems as judged by the investigator
- Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
- Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only)
- History of anaphylaxis to food
- Any known food allergies or food intolerance likely to affect the present study
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
- Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
- Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
- Participants who work in appetite or feeding related areas
- Post-menopausal (women only)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: High protein/high fat hard cheese
Served for breakfast together with bread, juice and coffee, tea or water
|
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
|
|
Comparador activo: High protein/low fat hard cheese
Served for breakfast together with bread, juice and coffee, tea or water
|
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
|
|
Experimental: Low protein/high fat creme cheese
Served for breakfast together with bread, juice and coffee, tea or water
|
Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total accumulated energy intake (overall intake of kJ from breakfast and ad libitum meal)
Periodo de tiempo: During the three hour study day
|
The primary outcome of the study is the total accumulated energy intake including the breakfast meal and the ad libitum test meal.
|
During the three hour study day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feelings of appetite
Periodo de tiempo: During the three hour study day
|
Secondary outcomes of the study are VAS scores for appetite every 30 minutes throughout the study test days where the feelings of appetite will be analysed in relation to energy content of the meals by calculating satiety quotients.
|
During the three hour study day
|
|
Pleasantness of meals and test products
Periodo de tiempo: After completing each meal at every test day , up to 200 minutes
|
Furthermore secondary outcomes are the VAS scores for the pleasantness of the meals after completing each meal as well as the pleasantness of the test products.
|
After completing each meal at every test day , up to 200 minutes
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Arne Astrup, Professor, University of Copenhagen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- B323
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .