Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
26 de noviembre de 2012 actualizado por: National Enzyme Company
A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a digestive enzyme dietary supplement product, on markers indicative of inflammation after a meal.
The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal.
A full complete blood count (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0 and 4 hours post-meal.
In addition, a questionaire on Gastrointestinal symptoms will be administered 4 hours post-meal.
The study hypothesis is that some or all of these potential markers of inflammation will increase following the meal, and the amount of increase in inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to the placebo.
In addition, it is hypothesized that levels of gastric discomfort as assessed by the questionaire will be reduced with the digestive enzyme compared to the placebo.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a digestive enzyme dietary supplement product, on markers indicative of inflammation after a meal.
The study design is a randomized, double-blind, placebo-controlled, cross-over type study.
The markers will be assessed by blood levels TNF-alpha, IL-1beta, IL-6, and hsCRP at times 0, 45 minutes, 2 hours and 4 hours post-meal.
A full blood CBC panel and an ESR blood test will also be conducted at times 0 and 4 hours post-meal.
In addition, a questionaire on Gastrointestinal symptoms will be administered 4 hours post-meal.
The study hypothesis is that some or all of these potential markers of inflammation will increase following the meal, and the amount of increase in inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to the placebo.
In addition, it is hypothesized that levels of gastric discomfort as assessed by the questionaire will be reduced with the digestive enzyme compared to the placebo.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
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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London, Ontario, Canadá, N6A 5R8
- KGK Synergize Inc.
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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
19 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- If female, not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgical with >1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Healthy as determined by laboratory results, medical history and physical exam
- Agrees to comply with study protocols
- Has given voluntary, written, informed consent to participate in the study -
Exclusion Criteria:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of prescribed medications for treatment
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
- History of bleeding disorders, or significant blood loss in the past 3 months
- Use of blood thinning medications.
- Use of anti-inflammatory medications, including over-the-counter pain relievers within the past 14 days.
- Use of prescription medication (other than birth control), vitamins, minerals or other natural health products within the past 3 days. .
- Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
- Allergy or sensitivity to study supplement ingredients, study meal ingredients or allergy or sensitivity to yeasts or molds/fungi.
- Participation in a clinical research trial within 30 days prior to randomization
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Use of fish oil supplements within 10 days of randomization and during the trial
Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
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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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Digestive Enzyme #2
A proprietary blend of dietary supplement enzymes in a capsule
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Contains dietary supplement proteases, lipases and carbohydrases
Otros nombres:
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Comparador de placebos: Placebo
Capsule identical to active arm containing only microcrystalline cellulose
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Capsule containing microcrystalline cellulose
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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TNF-alpha blood level change from time 0
Periodo de tiempo: 0, 45 minutes, 2 hours and 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours and 4 hours
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IL-1beta blood level change from time 0
Periodo de tiempo: 0, 45 minutes, 2 hours and 4 hours
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Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
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0, 45 minutes, 2 hours and 4 hours
|
|
IL-6 Blood Level change from time 0
Periodo de tiempo: 0, 45 minutes, 2 hours, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours, 4 hours
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hsCRP Blood Level change from time 0
Periodo de tiempo: 0, 45 minutes, 2 hours, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 45 minutes, 2 hours, 4 hours
|
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CBC Panel change from time 0
Periodo de tiempo: 0, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 4 hours
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ESR blood test change from time 0
Periodo de tiempo: 0, 4 hours
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Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
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0, 4 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Questionaire: Gastrointestinal Symptoms
Periodo de tiempo: 4 hours
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The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
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4 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Dale Wilson, MD, KGK Synergize
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 noviembre de 2012
Finalización primaria (Anticipado)
1 de diciembre de 2012
Finalización del estudio (Anticipado)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
14 de noviembre de 2012
Publicado por primera vez (Estimar)
20 de noviembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de noviembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
26 de noviembre de 2012
Última verificación
1 de noviembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NEC-001
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. .