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- Ensayo clínico NCT02285907
Protein Quality on Appetite Control, Reward-driven Eating, & Subsequent Food Intake
30 de abril de 2019 actualizado por: Heather Leidy, University of Missouri-Columbia
The Effects of Consuming Beef vs. Soy-rich Lunch Meals, Matched for Macronutrient Content or Serving Size, on Markers of Appetite Control and Satiety
To determine whether the consumption of a beef-rich lunch improves appetite control, satiety, and energy intake regulation while reducing food reward and food cravings compared to the consumption of a soy-rich lunch when matched for macronutrients and fiber content or when match for serving size.
The mechanisms of action surrounding the differential responses of beef versus soy proteins were also explored.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A randomized, crossover design, acute study was completed in 21 healthy adults (age 23 ±1 y; BMI: 23.8 ± 0.6 kg/m2) to compare 400 kcal lunch meals varying in protein quality.
Two separate comparisons were performed.
The first comparison consisted of macronutrient and fiber-matched lunches which varied in protein quality: 24 g beef protein vs. 24 g soy protein.
The second comparison matched serving size only: 1 serving of beef (24 g protein with 0 g fiber) vs. 1 serving of soy (14 g protein; 5 g fiber).
For each treatment, the participants completed 2 testing days per lunch treatment.
During the "Appetite Assessment Days," each participant reported to the lab to consume one of the lunch meals.
Pre and 7-h post-lunch appetite and cravings questionnaires were completed throughout each testing day along with plasma, hormonal responses, and plasma amino acid concentrations through repeated blood sampling.
Ad libitum dinner energy intake was also measured.
During the "Reward Assessment Days," the participants reported to our facility to again consume one of the lunch meals.
Pre and post-lunch neural responses to food stimuli, through functional magnetic resonance imaging (fMRI), occurred followed by ad libitum consumption of a lunch dessert.
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
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
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Missouri
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Columbia, Missouri, Estados Unidos, 65211
- University of Missouri
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-
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 30 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age range 18-30 y
- Normal to Overweight (BMI: 18-29.9 kg/m2)
- No metabolic, psychological, or neurological diseases/conditions
- Not currently/previously on a weight loss or other special diet (in the past 6 months)
- Not a vegetarian
- Right-handed (necessary for the fMRI analyses)
- Not pregnant
- Meets the MU-Brain Imaging Center Screening Criteria
- Have not given blood (for the American Red Cross in the past 6 months)
Exclusion Criteria:
- Age >30 y and <18y
- Under Weight or Obese (BMI: <18 kg/m2 or >29.9 kg/m2)
- Clinically diagnosed with diabetes (Type I or Type II), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes.
- Currently/previously on a weight loss or other special diet (in the past 6 months)
- Left-handed
- Claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces)
- Do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
- Pregnant
- Does not meeting the MU-Brain Imaging Center screening criteria
- Have given blood (for the American Red Cross) in the past 6 months or plan to give blood in the following 6 months
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Macronutrient and Fiber Matched BEEF
The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS).
Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
|
The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS).
Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
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Experimental: Macronutrient and Fiber Matched SOY
The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day.
SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
|
The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day.
SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
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|
Experimental: Serving Size Matched BEEF
The participants will consume the serving size matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
|
The participants will consume the serving size matched BEEF lunch on a single testing day.
BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
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Experimental: Serving Size Matched SOY
The participants will consume the serving size matched SOY lunch on a single testing day.
SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
|
The participants will consume the serving size matched SOY lunch on a single testing day.
SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Eating Initiation
Periodo de tiempo: 1 Day
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Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.
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1 Day
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Subsequent Food Intake
Periodo de tiempo: 1 Day
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Ad libitum dinner and snacks were provided.
Energy content and macronutrient content of these eating occasions were assessed.
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1 Day
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Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness
Periodo de tiempo: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days.
The questions are worded as "how strong is your feeling of" with anchors of "not at all" to "extremely."
Each reported score can be a minimum of 0 and a maximum of 100 mm.
niAUC was calculated for by computing the summation of the average change from baseline score (units of mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures.
For reported feelings of hunger, a higher score can be interpreted as "feeling more hungry."
For fullness, higher can be interpreted as "feeling more full."
Questionnaires were asked at baseline and about every 30 minutes throughout the day for a total of 20 questionnaires.
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- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY)
Periodo de tiempo: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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The samples were collected in test tubes containing ethylenediaminetetraacetic acid.
Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation.
The plasma was separated and stored at -80°C.
Plasma total glucagon-like peptide (GLP-1) and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies.
niAUC was calculated throughout the testing period by computing the summation of the average change from baseline score (units of pg/ml) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two time instances for a total of 20 blood samples.
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- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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Food Cue-stimulate fMRI Brain Scans
Periodo de tiempo: 3 hours
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Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images.
The pictures from each category were presented in blocks of images.
Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing).
To determine the effects of protein type on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing] and protein source (BEEF vs. SOY) comparisons within the macronutrient and fiber-matched condition and the serving size-matched conditions, separately.
The mean percent signal change in the maximum voxel within each region that displayed significant activation after the BEEF and SOY meals was then determined.
Talairach coordinates for each region are presented for each row as (x;y;z).
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3 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Plasma Amino Acids
Periodo de tiempo: - 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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Plasma amino acid concentrations were measured from the pre and hourly postprandial time points until dinner request following the Macronutrient and Fiber Matched BEEF meal and the Serving Size Matched Beef Meal.
An average amino acid concentration was then determined from the change from baseline concentration for all available time points.
Plasma amino acid analyses were performed through the University of Missouri-Columbia Agricultural Experiment Station Chemical Laboratories using cation-exchange chromatography (cIEC-HPLC) coupled with post-column ninhydrin derivatization and quantitation.
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- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 mayo de 2012
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
24 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
4 de noviembre de 2014
Publicado por primera vez (Estimar)
7 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UMissouri
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .