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MEALEffects of Chronic Almond Consumption at Meals or as Snacks on Appetite, Intake, Body Weight, Glycemia, Insulinemia and Lipids in Healthy Adults.

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Almonds 43g/day

+ Almonds 43g/day

+ Almonds 43g/day

Suplemento Dietético
Quiénes están siendo reclutados

Trastornos de la Nutrición+3

+ Enfermedades Nutricionales y Metabólicas

+ Signos y Síntomas

De 18 a 60 años
+13 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: octubre de 2010
Ver detalles del protocolo

Resumen

Patrocinador PrincipalPurdue University
Última actualización: 30 de mayo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de octubre de 2010

Fecha en la que se inscribió al primer participante.

Experiment protocol and measurements i) Oral glucose tolerance test (OGTT) sessions At baseline, participants attended a session where a standard OGTT with drinks containing 75 grams dextrose was performed following an overnight fasting. Serum glucose and insulin concentrations were measured at 0 and 120 minutes of the session. During the same session, height, weight (Tanita), body fat (air displacement plethysmography, BOD POD), waist circumference, and blood pressure were measured. Participants also completed a 24-hour dietary recall using a multi-pass interview method and standard questionnaires that assessed personality, eating behavior and habitual physical activity levels during the OGTT session. After the completion of this session, participants were asked to record their hourly appetite sensations, measured as "hunger", "fullness" and "desire to eat" on visual analog scales, during waking hours for a day before attending the next (clinical) visit. Participants repeated this session after four weeks of almond consumption. ii) Acute feeding sessions Within a week following the OGTT session, participants returned for an acute-feeding session, after an overnight fasting of at least 10 hours. This session began between 7:00 am and 8:00 am, and lasted for approximately 515 minutes. Upon arrival, an indwelling arm catheter was placed in the upper arm for blood sample collection. Participants rested for 15 minutes after catheter placement, before a baseline blood sample was drawn. Immediately after the first blood sample collection, a standard breakfast was served, and participants were instructed to consume the entire portion within 10 minutes. Subsequent blood samplings were performed at 15, 45, 60, 90, 120, 180, and 240 minutes after the breakfast, before a standard lunch was provided to the participants. Again, participants were given 10 minutes to consume the lunch, before blood samples were taken at similar intervals again (at 265, 295, 310, 340, 370, 430, and 490 minutes of the session). Participants randomized into the BF and LN groups received 43 grams of almonds together with their meals, while the MS and AS groups consumed 43 grams of almonds 120 minutes after breakfast and lunch respectively. Participants also recorded their "hunger", "fullness", and "desire to eat" sensations when blood samples were taken. During the acute-feeding session, activities that may alter appetite sensations (e.g. sleeping and watching movies containing food cues) were prohibited. Postprandial glucose, insulin and triacylglycerol concentrations were measured for all 15 samples collected from each participant. Participants in all almond groups group were also asked to rate their likings for the almonds they ingested using a general label magnitude scale, and their action responses to almonds using the "food action rating scale", a visual analog scale ranging from "I would eat the almonds only if I were forced to" to "I would eat this food every opportunity I had" anchored to the 2 extremes. This session was repeated again after four weeks of almond supplementation. iii) Weekly follow-ups Following the baseline acute-feeding session, participants were asked to consume 43 grams of almonds every day at times based on their group randomization. The CL group was instructed to avoid all nuts and seeds in the diet during the study period. All almonds were dry-roasted and lightly salted, and were pre-weighed and per-packaged for convenience. Except for the permission to adjust dietary intake due to almond supplement, participants were asked to maintain their dietary intakes and physical activity levels. A ruse (breath analysis) was introduced in order to enhance the compliance of participants to consuming almonds at the designated times of day. Compliance to almond consumption was assessed through fasting plasma α-tocopherol. Participants attended weekly visit (week-1, 2 and 3) after an overnight fasting, during which body weight was recorded and compliance to study protocol reinforced. During the week-2 visit, participants were also asked to complete a 24-hour dietary intake assessment using the multi-pass interview method and appetite sensation ratings on VAS at every waking hour for a day. On week-4, participants returned for OGTT and acute-feeding sessions as described above. The study protocol was approved by the Purdue University Institutional Review Board.

NCT01690936
Patrocinador PrincipalPurdue University
Última actualización: 30 de mayo de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 150 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 60 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos de la NutriciónEnfermedades Nutricionales y MetabólicasSignos y SíntomasCondiciones Patológicas, Signos y SíntomasPeso CorporalObesidad

Criterios

11 criterios de inclusión requeridos para participar
2-hour glucose 7.8-11.1 mmol/L

BMI 27-35

Eat at least 5 meals a day

Either one of the 6 conditions

Mostrar Más Criterios

2 criterios de exclusión impiden participar
Not willing to eat test foods and almonds

Nut allergy

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

5 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Almonds (43g/day) were consumed with breakfast for four weeks.

Grupo II

Experimental
Almonds (43g/day) were consumed alone as morning snacks for four weeks.

Grupo III

Experimental
Almonds (43g/day) were consumed with lunch for four weeks.

Grupo IV

Experimental
Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.

Grupo 5

Sin Intervención
Avoided all nuts and seeds

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Purdue University

West Lafayette, United StatesAbrir Purdue University en Google Maps
Completado1 Centros de Estudio