- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01266330
Dairy Attenuation of Metabolic Disease
Dairy Attenuation of Oxidative and Inflammatory Stress in Metabolic Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is designed to determine the effects of a dairy-rich diet on oxidative and inflammatory stress in metabolic syndrome patients in the presence and absence of obesity. Forty overweight and obese subjects (BMI 25-39.9) with metabolic syndrome as defined by NCEP ATP III criteria will be randomized to inadequate (0-0.5 daily serving) or adequate (3.5 servings) dairy diets in the presence of a eucaloric weight maintenance diet for 12 weeks. All subjects will undergo a 14-day lead-in period to establish a stable baseline of dietary and physiological measures (described below), followed by the 12-week intervention period. Baseline dietary assessments will be conducted by the project dietitian during the two-week lead-in period which will be used to provide an initial estimate of a maintenance level of caloric intake. This will be refined by calculating energy needs using DRI equations for calculation of age- and physical activity (PA) adjusted total energy expenditure (TEE) for men and women. Energy requirements will be confirmed via measurement of resting metabolic rate via indirect calorimetry.
Subjects will be given diets isocaloric to those consumed during the lead-in period, with macronutrient and fiber levels maintained equivalent at levels approximating the estimated U.S. average (described in Diets section). Subjects on the inadequate dairy diets will be assigned diets containing < 600 mg Ca/day and <0.5 daily serving of dairy foods, and subjects on the adequate dairy diets will be assigned diets containing 1200 - 1400 mg Ca/day and 3.5 daily servings of dairy (milk, yogurt, hard cheese). Two of the three dairy servings consumed daily by those on the high dairy diet will be milk and/or yogurt to ensure sufficient consumption of whey proteins. All subjects will be provided individual instruction, counseling and assessment from the study dietitian regarding dietary adherence and the development and reinforcement of strategies for continued success, and diets will be monitored weekly. Physical activity will be assessed using pedometer counts and maintained at approximately pre-study levels throughout the study. Pedometer counts will be recorded daily for the 14-day lead-in period and the value averaged to provide a pre-study baseline. Subjects will be asked to maintain the same level of activity (plus or minus 500 steps/day) and will use pedometers for self-assessment. Pedometer counts will be recorded and provided to the study staff on a weekly basis, along with the diet records.
Body weight, waist circumference, and blood pressure will be measured weekly and body composition (via dual X-ray absorptiometry) will be measured at weeks 0, 4 and 12 of the dietary intervention. Resting metabolic rate and respiratory quotient will be assessed at weeks 0 and 12. Oxidative burden will be assessed by measurement of plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL at weeks 0, 1, 4 and 12, and inflammatory stress will be assessed by measurement of IL-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α levels in plasma at the same time intervals. Glucose tolerance, HOMAIR, fasting plasma lipids, PTH and 1,25-(OH)2-D levels will be determined at the same time intervals (0, 4, and 12 weeks). All data will be analyzed via two-factor multivariate analysis of variance (MANOVA).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37996
- The University of Tennessee Nutrition and Metabolic Research Laboratory
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
• Diagnosis of metabolic syndrome as defined by NCEP ATP III criteria: Presence of three or more of the following risk determinants:
Abdominal obesity (This criterion must be met by all obese subjects entered into the study)
- Waist circumference >102 cm for males
- Waist circumference >88 cm for females
- Triglycerides >150 mg/dL
- HDL cholesterol <40 mg/dL (men); < 50 mg/dL (women)
- Blood pressure >130/>85 mm Hg (This criterion must be met by all subjects [overweight and obese] entered into the study).
Fasting glucose >100 mg/dL
- Body mass index (BMI) 25-39.9
- Age 18-50 years
- Weight stable: no more than 1 kg weight gain or loss during past four weeks
Exclusion Criteria:
• BMI < 25 or >40
- Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
- Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
- history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
- history of eating disorder
- presence of active gastrointestinal disorders such as malabsorption syndromes
- pregnancy or lactation
- use of obesity pharmacotherapeutic agents within the last 6 months
- use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 3 months
- Chronic use of anti-inflammatory agents within the last four weeks
- Use of antioxidant supplements within the last four weeks
- Recent (current or past 12 weeks) use of any psychotropic medication
- Recent (past four weeks) initiation of an exercise program
- Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
- Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
- Recent (past 12-weeks) history of tobacco use
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 |
|---|---|
|
Comparador activo: Low Dairy
<0.5 standard dairy servings/day
|
Less than 0.5 standard servings of dairy products per day
|
|
Experimental: Adequate dairy
3.5 standard dairy servings per day
|
3.5 standard servings of dairy foods per day
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peso corporal
Periodo de tiempo: 12 semanas
|
12 semanas
|
|
|
Body composition
Periodo de tiempo: 12 weeks
|
DEXA assessment
|
12 weeks
|
|
Oxidative Stress
Periodo de tiempo: 12 weeks
|
plasma malonaldehyde, 8-isoprostane F2α and oxidized LDL
|
12 weeks
|
|
Inflammatory stress
Periodo de tiempo: 12 weeks
|
Plasma L-6, IL-15, MCP, C-reactive protein, adiponectin and TNF-α
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Presión sanguínea
Periodo de tiempo: 12 semanas
|
12 semanas
|
|
|
Lípidos
Periodo de tiempo: 12 semanas
|
12 semanas
|
|
|
Insulin sensitivituy
Periodo de tiempo: 12 weeks
|
Glucose, insulin and HOMA
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael B. Zemel, Ph.D., The University of Tennessee
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R011770040
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