- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01089049
Effect of a Natural Health Product on Urinary Estrogen Metabolites
A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.
The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.
Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Guelph, Ontario, Canadá, N1G0B4
- Nutrasource Diagnostics Inc
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older
- Healthy
- Willing to collect urine samples and to have blood drawn
- Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
- Pre-menopausal (48 subjects)
Exclusion Criteria:
- Diagnosed with any major illness(e.g. cancer)
- Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
- Women taking blood thinner or thyroid medication (including warfarin)
- Known allergy to any of the any of the study ingredients
- Pregnancy or lactation
- Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment
- Family history of breast cancer risk
- Post-menopausal women on HRT
- Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.)
- All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Pre-Menopausal
|
Two capsules daily, with meals.
FemMED Breast Health Formula containing lignans.
|
Experimental: Post-Menopausal
|
Two capsules daily, with meals.
FemMED Breast Health Formula containing lignans.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
2-OH Hydroxy Estrone: 16-alpha-OH Estrone
Periodo de tiempo: Day 0, Day 28
|
2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. |
Day 0, Day 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Enterolactone
Periodo de tiempo: Day 0, Day 28
|
Enterolactone is a lignan formed by the action of intestinal bacteria on lignan precursors found in plants. For the purpose of this study, enterolactone will serve as an indicator of compliance/dietary intake of lignans. Blood samples would be collected and assessed for levels of enterolactone. |
Day 0, Day 28
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Maggie Laidlaw, P.hD, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NDI: 136987
- NHPD136987 (Otro identificador: Natural Health Products Directorate, Health Canada)
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. .
Ensayos clínicos sobre Cáncer de mama
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos