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Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults. (FINS)

17 de mayo de 2016 actualizado por: Anne Birgitte Raben, University of Copenhagen

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.

The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety. The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.

Descripción general del estudio

Estado

Terminado

Condiciones

Exceso de peso

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

Fase

No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Dinamarca
- Frederiksberg
  - Copenhagen, Frederiksberg, Dinamarca, 1958
    - Department of Nutrition, Exercise and Sports

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 50 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Healthy men and women
Between 18 and 50 years of age
BMI between 25.0 and 30.0 kg×m-2
Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit)
Non-smoker

Exclusion Criteria:

Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
Menopausal women and women with an irregular menstrual cycle
Food allergies
Substance abuse
Vigorous physical activity more than 10 hours/week
Alcohol intake above the recommendations from the Danish Health and Medicines Authority
Caffeine intake above 300 mg/day
Night- or shift work
Blood donation <1 month before study commencement and during study period
Simultaneous participation in other clinical studies
Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Prevención
Asignación: Aleatorizado
Modelo Intervencionista: Asignación cruzada
Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Experimental: Salmon vs. veal and CHO with low or high GI In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with salmon served with tomato sauce and other accompaniments with low GI Meat balls with salmon served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI	Otro: Fish and carbohydrats with low or high GI Otro: Veal and carbohydrats with low or high GI
Experimental: Cod vs. veal and CHO with low or high GI In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals: Meat balls with codfish served with tomato sauce and other accompaniments with low GI Meat balls with codfish served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI	Otro: Fish and carbohydrats with low or high GI Otro: Veal and carbohydrats with low or high GI

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Salmon vs. veal and CHO with low or high GI

In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:

Meat balls with salmon served with tomato sauce and other accompaniments with low GI
Meat balls with salmon served with tomato sauce and other accompaniments with high GI
Meat balls with veal served with tomato sauce and other accompaniments with low GI
Meat balls with veal served with tomato sauce and other accompaniments with high GI

Otro: Fish and carbohydrats with low or high GI

Otro: Veal and carbohydrats with low or high GI

Experimental: Cod vs. veal and CHO with low or high GI

In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:

Meat balls with codfish served with tomato sauce and other accompaniments with low GI
Meat balls with codfish served with tomato sauce and other accompaniments with high GI
Meat balls with veal served with tomato sauce and other accompaniments with low GI
Meat balls with veal served with tomato sauce and other accompaniments with high GI

Otro: Fish and carbohydrats with low or high GI

Otro: Veal and carbohydrats with low or high GI

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Differences in diet induced thermogenesis between the four test meals Periodo de tiempo: 3 hours	In the following three hours after eating the test meal respiratory gas exchange will be measured 6x25 minutes with 5 minutes breaks in between each measurement. Diet induced thermogenesis (DIT) will be measured by indirect calorimetry using a ventilated hood system. Each measurement will last for 25 minutes of which the last 20 minutes will be used for calculation of energy expenditure.	3 hours

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Satiety Periodo de tiempo: 3 hours	Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)	3 hours
Food preferences Periodo de tiempo: 3 hours	In an attempt to measure spontaneous energy intake and macronutrient preferences in an experimental context, the participants will be given an ad libitum buffet lunch at noon. A cold and hot buffet-style lunch comprising a variety of foods (representing a wide selection of food groups) will be offered after the last measurement of gas exchange and the participants will be instructed to eat ad libitum.	3 hours
Glucose Periodo de tiempo: 3 hours	Blood sample	3 hours
Insulin Periodo de tiempo: 3 hours	Blood sample	3 hours
Glucagon Periodo de tiempo: 3 hours	Blood sample	3 hours
C-peptide Periodo de tiempo: 3 hours	Blood sample	3 hours
Plasma amino acids Periodo de tiempo: 3 hours	Blood samples	3 hours
Appetite regulating hormones Periodo de tiempo: 3 hours	e.g. glucagon-like peptide-1 (GLP-1)	3 hours
Free fatty acids Periodo de tiempo: 3 hours	Blood sample	3 hours
Glycerol Periodo de tiempo: 3 hours	Blood sample	3 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Copenhagen

Colaboradores

The Fisheries and Aquaculture Industry Research Fund

National Institute of Nutrition and Seafood Research, Norway

Investigadores

Investigador principal: Anne Raben, Prof, Prof at the department of Nutrition, Exercise and Sports

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2014

Finalización primaria (Actual)

1 de enero de 2016

Finalización del estudio (Actual)

1 de enero de 2016

Fechas de registro del estudio

Enviado por primera vez

29 de octubre de 2014

Primero enviado que cumplió con los criterios de control de calidad

11 de mayo de 2016

Publicado por primera vez (Estimar)

12 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de mayo de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

17 de mayo de 2016

Última verificación

1 de mayo de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

H-1-2014-038 (B314)

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. .

Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults. (FINS)