- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03729700
The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome
Descripción general del estudio
Descripción detallada
This study will be a 24 week supplementation study that utilizes two study groups: 1) control group and 2) almond supplementation: 20% energy intake. This will be a randomized, rater-blinded, and controlled study. There will be a total of 60 subjects, with 30 assigned to the control group and 30 assigned to almond supplementation.
Subjects will be recruited from the UC Davis Dermatology Clinic, UC Davis Main campus, California State University- Sacramento, and from the surrounding community physicians and the community in a 100 mile radius. The greater Sacramento area has a population of over 2 million to draw from and recruitment will be conducted through the use of Social Media and flyer based recruitment. Postmenopausal women have previous been recruited successfully in a previous study. The study visits will be performed at the UC Davis Dermatology Clinic located at 3301 C Street, Suite 1400, Sacramento, CA 95816.
Investigators will collect medical history and current medications from study participants- this is outlined in the HIPAA form. The two intervention groups will consist of those receiving almonds and those that are receiving a calorie matched snack. The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials of tree nuts [5, 6]. The control snack will be a typical western diet snack (see Table 1) . The calorie matched snacks are commercially available prepackaged snack items that will be purchased from Costco. Once a subject has met inclusion criteria and has signed IRB consent, anthropometric data will be obtained, 1-24 hour recall will be collected, training will be provided for recording dietary records, and estimated caloric needs will be calculated. Estimated energy needs (EER) will be determined using the Mifflin-St. Jeor equation and total daily energy needs (TDE) calculated as EER x activity factor of 1.3-1.5 for sedentary to average activity, or a higher activity level as indicated. A representative example of a 60 year old woman, 5'4", 140 pounds with typical activity level yields TDE of approximately 1,600 - 1,800 kcal/day, and 20% E of 320-360 kcal/day. The intervention and control snacks would be 56.7 g of almonds and 56.7 g pretzel + one-24 g chewy granola bar, respectively.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Sacramento, California, Estados Unidos, 95816
- UC Davis Department of Dermatology, Clinical Trials Unit
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Postmenopausal women
- Fitzpatrick skin types 1 and 2
- Able to follow dietary intervention and attend all study visits
Exclusion Criteria:
- Those with a nut allergy
- Current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack-year history of smoking, as smoking is a independent risk factor and serves as a confounder for the development of facial wrinkles
- Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos), as this can be a confounder for the development of facial wrinkles
- Those that already obtain 20% of their energy intake from nut consumption
- Those with implausible reported energy intakes of <1,000 kcal/d or >3,000 kcal/d
- Individuals who are unwilling to discontinue vitamin E containing supplements and food sources during the washout and intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Almond supplementation
The almond dose will be provided as 20% of total energy (20% E) in the diet.
This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials.
|
The almond dose will be provided as 20% of total energy (20% E) in the diet.
|
|
Sin intervención: Control snack
The control snack will be a typical western diet snack.
The calorie-matched control snack will be commercially available individually wrapped food products.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in wrinkle severity
Periodo de tiempo: 24 weeks
|
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks.
The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad.
The investigator has already validated this measurement tool against standard clinical grading of facial wrinkles.
|
24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in facial pigmentation
Periodo de tiempo: 24 weeks
|
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks.
The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad.
This system can assess facial pigmentation evenness and average intensity.
The investigator has already validated this measurement tool against standard clinical grading of facial pigmentation.
|
24 weeks
|
|
Change in appearance of facial wrinkles on lateral canthi
Periodo de tiempo: 24 weeks
|
Two blinded physician graders will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet").
|
24 weeks
|
|
Change in facial sebum production
Periodo de tiempo: 24 weeks
|
Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate.
Sebum excretion rate will be measured at baseline, 8 weeks, 16 weeks, and 24 weeks.
|
24 weeks
|
|
Change in the serum profile
Periodo de tiempo: 24 weeks
|
Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
|
24 weeks
|
|
Change in sebum lipid profile
Periodo de tiempo: 24 weeks
|
Change in the sebum lipid profile assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1257688
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .