Weight Loss Diet Study: Low Carbohydrate vs. Low Fat and Insulin Resistance Status
Low-Carbohydrate Diet
+ Low-Fat Diet
+ Low-Carbohydrate Diet
Peso Corporal+8
+ Cambios en el Peso Corporal
+ Hiperinsulinismo
Estudio de Prevención
Resumen
Fecha de inicio: 1 de abril de 2012
Fecha en la que se inscribió al primer participante.The investigators hope to learn whether matching the weight loss diet to one's insulin resistance status will increase weight loss the success. The relevance of these findings is highlighted by the fact that the national recommendations for weight loss are to follow a high-carbohydrate, low-fat diet. This would imply that about half the population has been given the wrong advice in regards to the most successful dietary pattern for weight loss. Plasma fatty acid composition patterns have been shown to be associated with both insulin resistance and/or carbohydrate intake. As secondary analyses, the investigators will explore: (1) differences in plasma fatty acid composition between insulin sensitive and resistant participants at baseline; (2) the correlations between insulin markers and plasma fatty acid composition at baseline; (3) the interaction between insulin status and diet on 6-month changes in the plasma fatty acid composition; (4) plasma fatty acid composition changes in participants on low fat and low carbohydrate diets after 6 months; and (5) the correlations between changes in insulin markers, dietary components, and plasma fatty acid composition after 6 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 61 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 50 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
Criterios
Inclusion Criteria: Age: > or = 18 years of age Women: Pre-menopausal (self-report) and <50 years of age Men: <50 years of age Race/Ethnicity: All BMI (body mass index): 28-40 kg/m2 (need to lose >10% body weight to achieve healthy BMI) Body weight stable for the last two months, and not actively on a weight loss plan No plans to move from the area over the next 14 months Available and able to participate in the evaluations and intervention for the study period Willing to accept random assignment To enhance study generalizability, people on medications not noted below as specific exclusions can participate if they have been stable on such medications for at least three months Ability and willingness to give written informed consent No known active psychiatric illness Exclusion Criteria: Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 12 months; no menstruation for the previous 12 months Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction, hypertension (except for those stable on hypertensive medications) (<6 months) (patient self-report and, if available, review of labs from primary care provider) Smokers (because of effect on weight and lipids) History of serious arrhythmias, or cerebrovascular disease Uncontrolled hyper- or hypothyroidism (TSH not within normal limits) Medications: Lipid lowering, diabetes medications, and those known to affect weight/energy expenditure Excessive alcohol intake (self-reported, >3 drinks/day)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoObjetivos 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
Stanford University School of Medicine
Stanford, United StatesAbrir Stanford University School of Medicine en Google Maps