Comparing Diet and Exercise Approaches in Women (CWW)
30 de abril de 2020 actualizado por: Richard B. Kreider, Texas A&M University
Comparison of Two Diet and Exercise Approaches on Weight Loss and Health Outcomes in Obese Women
The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women.
The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day).
The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone.
Researchers in the Exercise and Sport Nutrition Lab at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program.
Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness.
The Weight Watchers program is another popular weight loss program.
It provides a systematic approach to diet and exercise throughout the weight-loss process.
Consequently we are interested in comparing the efficacy of both programs to one another.
The purpose of this study is to determine whether following a Curves high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 30-days several times during 16 weeks of participating in the Curves fitness program promotes stepwise reductions in body weight, improvements in body composition and/or improvements in markers of fitness and health better than following the Weight Watchers Momentum Program for the same time period.
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
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 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Participant is female
- Participant is between the ages of 18 and 45
- Participant is sedentary and overweight (BMI > 27)
Exclusion Criteria:
- Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism;
- Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
- Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
- Participant has been pregnant or lactating within the past 12 months or are planning to become pregnant during the next 12 months;
- Participant is involved in a planned exercise program (> 30 min./d. 3 d./wk.) within 3 - 6 months prior to the start of the study;
- Participant has taken any weight loss medications and/or dietary supplements that may affect muscle mass or body weight during the three month time period prior to beginning the study;
- Participant has a recent history of weight change (+/- 7 lbs. within the last 3 months).
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
No diet or exercise intervention
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Experimental: Curves Program
The Curves group will follow the high protein/low fat diet (30% carbohydrate, 45% protein, 25% fat) for 7-days at 1,200 kcals/day and then 1,500 kcals/day for the remaining 21-days of the 30-day diet period.
The participants will then consume a normal maintenance diet (2,200 kcals/d; 45% carbohydrate, 30% protein, 25% fat) for 30-days.
During the maintenance period, participants will diet for 2-days at 1,200 kcals/day if they gain 3 pounds of weight.
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The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups.
These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.
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Experimental: Weight Watchers Momentum Program
This program is based on the Weight Watchers four pillar approach (food, exercise, behavior and support).
The Momentum Program uses POINTS values to help keep track of what you eat.
A POINTS "budget" will be personalized for you at the weekly meetings.
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The Weight Watchers program encourages one to increase physical activity.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body Composition: Body Weight
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Changes in body weight (lbs.
body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Body Composition: Fat Mass
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (lbs.
fat mass) obtained via Dual-Energy X-Ray Absorptiometry (DXA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Body Composition: Lean Mass
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (lbs.
lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Body Composition: Percent Body Fat
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Energy Homeostasis: Resting Energy Expenditure (REE)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in bench press 1 Repetition Maximum (1RM) obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
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Changes in leg press 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
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Changes in total repetitions at 80% of 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 16 weeks
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Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
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Changes in total repetitions at 80% of 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 16 weeks
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Lipid Panel: Cholesterol
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: HDL Cholesterol
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: LDL Cholesterol
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: Triglycerides
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
|
Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Lipid Panel: Cholesterol:HDL Ratio
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in cholesterol to HDL cholesterol ratio obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Comprehensive Metabolic Panel (CMP): Glucose
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hormones: Insulin
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in insulin obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hormones: Leptin
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in leptin obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR): Homeostatic Model Assessment of Insulin Resistance
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in HOMA-IR obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hemodynamic Variable: Resting Heart Rate (HR)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in resting heart rate (HR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in resting systolic blood pressure (SBP) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Hemodynamic Variable: Resting Diastolic Blood Pressure (SBP)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Changes in resting diastolic blood pressure (DBP) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Anthropometric Measures: Waist Circumference
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Anthropometric Measures: Hip Circumference
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Anthropometric Measures: Waist to Hip Ratio
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Exercise Capacity: Peak Exercise Capacity (VO2)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
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Changes in exercise capacity (VO2 max) obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 16 weeks
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Exercise Capacity: Time to Peak Exercise Capacity (time to peak VO2)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 16 weeks
|
Changes in exercise capacity (time to peak VO2 max) obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 16 weeks
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Dietary Energy Intake: Total Caloric Intake (kcals/d)
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in caloric/energy intake (kcals/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
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Dietary Energy Intake: Carbohydrate
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in dietary carbohydrate intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Dietary Energy Intake: Fat
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
|
Changes in dietary fat intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Dietary Energy Intake: Protein
Periodo de tiempo: Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Changes in dietary protein intake (g/d and g/kg/d) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
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Measured prior to supplementation (Pre), and after 4, 6, 10, 12 and 16 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Richard B Kreider, PhD, Texas A&M University
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)
19 de abril de 2010
Finalización primaria (Actual)
22 de marzo de 2012
Finalización del estudio (Actual)
22 de marzo de 2012
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2020
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2020
Publicado por primera vez (Actual)
4 de mayo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB2010-0130F
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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
producto fabricado y exportado desde los 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. .