High Fat - High Protein Diet in the Treatment of Obesity

Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity

Patrocinadores

Patrocinador principal: Rockefeller University

Colaborador: St. Luke's-Roosevelt Hospital Center

Fuente Rockefeller University
Resumen breve

The purpose of this study is to examine the effects of a low calorie high fat/protein diet on body fat and body composition in overweight and obese subjects. The investigators will also test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance, cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and feelings of fullness.

Descripción detallada

Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.

Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to eat an average American diet. This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fat/protein diet. During the weight loss period, calories will be cut by 50% compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and subjects will be encouraged to maintain their usual activity level.

Females of reproductive age need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during each phase of the study.

Estado general Terminated
Fecha de inicio March 2006
Fecha de Terminación December 2014
Fecha de finalización primaria December 2014
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Visceral adipose tissue after 6 weeks
Resultado secundario
Medida Periodo de tiempo
Body composition, fluid and electrolyte balance, lipids/lipoprotein metabolism, markers of inflammation, glucose and insulin metabolism, fat hormones, blood pressure and measures of satiety. after 6 weeks
Inscripción 8
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Low calorie high fat/protein diet

Descripción: 6 weeks of caloric restriction (50%) on a high fat/protein diet

Etiqueta de grupo de brazo: Low calorie high fat/protein diet

Elegibilidad

Criterios:

Inclusion Criteria:

- Body mass index (BMI) of 30 to 34.9 or

- BMI of 25 to 29.9 and a waist circumference > 88cm (35in)

- Pre-menopausal-

Exclusion Criteria:

- High Blood Pressure

- High Cholesterol

- Diabetes

- Anemia

- Liver disease

- Kidney disease

- HIV positive

- Syphilis

- Hepatitis B/C positive

Género: Female

Edad mínima: 25 Years

Edad máxima: 50 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Jan L. Breslow, MD Principal Investigator The Rockefeller University Hospital
Ubicación
Instalaciones: The Rockefeller University Hospital
Ubicacion Paises

United States

Fecha de verificación

June 2015

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Low calorie high fat/protein diet

Tipo: Experimental

Descripción: Low calorie high fat/protein diet

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov