- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04294706
Effects of Hemp Oil on Markers of Optimal Wellness, Stress Resilience and Recovery in Healthy Subjects
3 de marzo de 2020 actualizado por: The Center for Applied Health Sciences, LLC
The purpose of this placebo-controlled, double-blind study is to determine the effects of a commercially available (i.e.
dietary supplement) Hemp Oil Extract product on various markers of physical and mental stress resilience, and perceived recovery from normal daily physical & mental stress.
Secondary purposes are to collect information on perceived appetite, mood, feelings of wellbeing, sleep quality, body composition and safety information via standard clinical chemistry panels of sera and plasma.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
65
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
-
-
Ohio
-
Canfield, Ohio, Estados Unidos, 44406
- The Center for Applied Health Sciences
-
-
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
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects provide written and dated informed consent to participate in an IRB approved study.
- Subjects are in good health as determined by medical history and routine blood chemistries.
- Subjects are male or female between the ages of 18 and 55 (inclusive).
- Female subjects must agree to use barrier contraceptive methods during sexual intercourse for the duration of the study. All females will undergo pregnancy testing (urine HCG screen) before being screened and at each visit unless they present evidence of surgical sterilization by tubal ligation, bilateral oophorectomy or hysterectomy.
- Subjects have a Body Mass Index of 25-35.
- Subjects are willing and able to comply with the daily activity and supplement protocol.
- Subject is willing and able to comply with the visit schedule.
- Subjects are normotensive (resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg), have a normal resting heart rate (<90 per minute).
Exclusion Criteria:
- Subjects that currently exercise more than three times per week.
- Subject has used weight loss medications within the past three months of Screening visit.
- Subject is on thyroid medication at a dose that is not considered stable. Stable is defined as using the same dose consistently for at least 90 days.
- Subjects with any metabolic disorder including known electrolyte abnormalities, diabetes (or fasting glucose ≥126 mg/dL at the screening visit), unstable or unmanaged thyroid disease, or hypogonadism.
- Subjects with a history of hepato-renal, musculoskeletal, autoimmune, neurologic disease, or any other medical condition deemed exclusionary by the medical staff.
- Subjects taking anti-anxiety, anti-depressant, psychotropic hyperlipidemic, hypoglycemic, anti-coagulant or androgenic medications; nitrates/nitrate derivatives, and PDE-5 inhibitors; and other vasodilatory agents such as calcium channel blockers and beta blockers.
- Subject has an active gastrointestinal disorder such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- Subjects who have taken anabolic steroids, growth hormone, IGF-1 or other anabolic drugs within the past year.
- Subjects who are pregnant, trying to become pregnant, or who are nursing.
- Female participants who are < 120 days postpartum before enrolling.
- Subjects who have taken any nutritional supplements that may affect sleep, mood or healthy stress response (including but not limited to Ashwagandha, Valerian root, Melatonin, L-theanine, 5-HTP), or that may affect anabolic/catabolic hormone levels (e.g., androstenedione, DHEA, etc.) within four weeks prior to the start of the study.
- Subjects who have gained or lost more than 5 lbs within 30 days prior to the start of the study.
- Subjects with history of heart disease, peripheral vascular disorders or vaso-occlusive or vasospastic syndromes, psychiatric disorders, or history of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin.
- Subject has a recent history of (within 3 months of Screening Visit) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has been hospitalized within the past one-year for any mental or emotional illness.
- Subject has an active infection or sign/symptoms of an infection.
- Subject has dietary tendencies that may be representative of disordered eating (in the opinion of the Investigator).
- Subjects who had any known allergy to any of the ingredients in any of the test products.
- Subjects who are participating in other research studies.
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- Subjects who smoked or used any tobacco or nicotine containing products within the past year.
- Subjects with syndromes or prescribed medications that may influence body composition, or CVD (e.g. prednisone, Ritalin, Adderall, GH); also protease inhibitors/antivirals (nucleic acid analogs).
- Subjects with orthopedic limitations or injuries that would preclude them from the physical activity intervention in this study.
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Hemp arm
Randomly assignment to Hemp arm (60 mg/day of hemp oil extract x 6 weeks)
|
Hemp oil
|
|
Comparador de placebos: Placebo arm
Randomly assigned to Placebo arm (60 mg/day of cellulose x 6 weeks)
|
Hemp oil
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep quality
Periodo de tiempo: baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
baseline
|
|
Sleep quality
Periodo de tiempo: week 3
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
week 3
|
|
Sleep quality
Periodo de tiempo: week 6
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
week 6
|
|
Stress
Periodo de tiempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
|
Stress
Periodo de tiempo: Week 3
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 3
|
|
Stress
Periodo de tiempo: Week 6
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 6
|
|
Well-being
Periodo de tiempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
|
Well-being
Periodo de tiempo: Week 3
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 3
|
|
Well-being
Periodo de tiempo: Week 6
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 6
|
|
Readiness to perform exercise
Periodo de tiempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
|
Readiness to perform exercise
Periodo de tiempo: Week 3
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 3
|
|
Readiness to perform exercise
Periodo de tiempo: Week 6
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 6
|
|
Appetite
Periodo de tiempo: Baseline
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Baseline
|
|
Appetite
Periodo de tiempo: Week 3
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 3
|
|
Appetite
Periodo de tiempo: Week 6
|
A visual analog scale constructed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings.
|
Week 6
|
|
Body composition
Periodo de tiempo: Baseline
|
DXA measurement
|
Baseline
|
|
Body composition
Periodo de tiempo: Week 3
|
DXA measurement
|
Week 3
|
|
Body composition
Periodo de tiempo: Week 6
|
DXA measurement
|
Week 6
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure
Periodo de tiempo: Baseline
|
Measured in mm Hg
|
Baseline
|
|
Blood pressure
Periodo de tiempo: Week 3
|
Measured in mm Hg
|
Week 3
|
|
Blood pressure
Periodo de tiempo: Week 6
|
Measured in mm Hg
|
Week 6
|
|
Plasma liver enzyme
Periodo de tiempo: Baseline
|
Alanine aminotransferase
|
Baseline
|
|
Plasma liver enzyme
Periodo de tiempo: Week 3
|
Alanine aminotransferase
|
Week 3
|
|
Plasma liver enzyme
Periodo de tiempo: Week 6
|
Alanine aminotransferase
|
Week 6
|
|
Plasma liver enzyme
Periodo de tiempo: Baseline
|
Aspartate aminotransferase
|
Baseline
|
|
Plasma liver enzyme
Periodo de tiempo: Week 3
|
Aspartate aminotransferase
|
Week 3
|
|
Plasma liver enzyme
Periodo de tiempo: Week 6
|
Aspartate aminotransferase
|
Week 6
|
|
Plasma Lipid panel
Periodo de tiempo: Baseline
|
Total cholesterol, LDL, HDL and triglycerides
|
Baseline
|
|
Plasma Lipid panel
Periodo de tiempo: Week 3
|
Total cholesterol, LDL, HDL and triglycerides
|
Week 3
|
|
Plasma Lipid panel
Periodo de tiempo: Week 6
|
Total cholesterol, LDL, HDL and triglycerides
|
Week 6
|
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 (Actual)
27 de agosto de 2018
Finalización primaria (Actual)
29 de agosto de 2019
Finalización del estudio (Actual)
29 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
2 de marzo de 2020
Primero enviado que cumplió con los criterios de control de calidad
2 de marzo de 2020
Publicado por primera vez (Actual)
4 de marzo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CVSI-001-2018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
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
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. .