Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability
26 de octubre de 2020 actualizado por: Amanda Wright, Ph.D., University of Guelph
Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males
The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e.
crystalline) states.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A double blinded randomized cross-over acute meal study will be carried out in which 15 healthy male participants will attend four study visits, separated by at least one week.
On each study visit, fasted participants will consume either the emulsion with solid or liquid droplets and that is either acid stable or acid unstable, in a randomized order.
All emulsions will have similar compositions, mainly differing in terms of droplet physical state, achieved by using lipids with different melting temperature.
The emulsions will also contrast in terms of colloidal stability to acids, achieved by using different emulsifiers.
This will isolate the impacts of physical state and acid stability, and their interactions.
Postprandial lipemia, gastric emptying and satiety will be measured for 6 hours after consumption of each test beverage.
The study meals will include crushed acetaminophen, the appearance of which will be measured in plasma as a measure of liquid content gastric emptying.
It will also include periodic measurements of the gastric antrum area by ultrasound to assess the rate of gastric emptying.
Participants will be asked to maintain their usual lifestyle habits throughout the study, with some changes in the 48 hour period leading up to each of the four visits.
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
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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Ontario
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Guelph, Ontario, Canadá, N1G 2W1
- University of Guelph
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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 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- BMI of 18 - 26 kg/m2
- generally healthy
- non-smoking
- non to moderate alcohol drinkers
- fasting plasma cholesterol level <5.2 mmol/L
- plasma triacylglycerol level <1.7 mmol/L
- plasma glucose level <5.6 mmol/L
- no history of gastric surgeries
Exclusion Criteria:
- History of major medical conditions
- taking prescription medications/ over the counter medications
- taking natural health products/ dietary supplements (other than a multivitamin)
- oral antibiotic use in the previous 3 months
- planning to take oral antibiotics in the next 3 months
- food allergy/anaphylactic/life-threatening allergy
- smokers/ regular users of recreational drugs
- elite/ training athletes
- significant weight loss/ gain during the past 3 months
- previous reaction/ sensitivity to acetaminophen
- inability to avoid taking acetaminophen for 48 hours
- sensitivity to the artificial sweetener Sugar Twin® Sucralose and artificial vanilla extract
- not willing to consume Sugar Twin® Sucralose or Artificial vanilla.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Acid stable emulsion with solid droplets
Acid stable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
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This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)
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Experimental: Acid stable emulsion with liquid droplets
Acid stable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)
|
|
Experimental: Acid unstable emulsion with solid droplets
Acid unstable emulsion with solid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
|
Experimental: Acid unstable emulsion with liquid droplets
Acid unstable emulsion with liquid droplets will be consumed by participants in one study visit along with 1500 mg of crushed and dissolved acetaminophen.
|
This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid.
It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e.
crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart.
The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in triacylglycerol blood concentrations
Periodo de tiempo: 6 hours
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Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)
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6 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant visual analogue scale ratings of feelings of satiety
Periodo de tiempo: 6 hours
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Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage.
0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated.
The distance from the left end of the scale will be measured (cm)
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6 hours
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Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations
Periodo de tiempo: 6 hours
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The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)
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6 hours
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Changes in fatty acid concentration of blood triacylglycerols
Periodo de tiempo: 6 hour
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Analysis based on fasting and postprandial blood sample analysis (mmol/L)
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6 hour
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Changes in satiety hormone blood concentrations
Periodo de tiempo: 6 hours
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Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)
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6 hours
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Changes in concentrations of inflammatory blood markers (ug/mL)
Periodo de tiempo: 6 hours
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Analysis of blood for CD14 and LBP at fasting and postprandially
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6 hours
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Rate of gastric emptying by measuring the change in the gastric antrum area
Periodo de tiempo: 6 hours
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Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)
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6 hours
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Changes in glucose blood concentrations
Periodo de tiempo: 6 hour
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Based on determination of fasting and postprandial blood glucose (mg/dL)
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6 hour
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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.
Publicaciones Generales
- Hamad S, Tari NR, Mathiyalagan G, Wright AJ. Emulsion acid colloidal stability and droplet crystallinity modulate postprandial gastric emptying and short-term satiety: a randomized, double-blinded, crossover, controlled trial in healthy adult males. Am J Clin Nutr. 2021 Sep 1;114(3):997-1011. doi: 10.1093/ajcn/nqab116.
- Hamad S, Thilakarathna SH, Cuncins A, Brown M, Wright AJ. Emulsion Droplet Crystallinity Attenuates Short-Term Satiety in Healthy Adult Males: A Randomized, Double-Blinded, Crossover, Acute Meal Study. J Nutr. 2020 Sep 1;150(9):2295-2304. doi: 10.1093/jn/nxaa164.
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 (Actual)
12 de junio de 2019
Finalización primaria (Actual)
1 de marzo de 2020
Finalización del estudio (Actual)
31 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2019
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2019
Publicado por primera vez (Actual)
18 de junio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 19-04-003
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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