Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Expectancy, Self-Efficacy and Outcomes in Metabolic Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity; these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes. The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
This study will last 12 weeks. Participants will be randomly assigned to one of three arms. Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50% chance of receiving either the supplement or placebo; participants in Arm 3 will receive placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after the follow-up visit. Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin, cholesterol, and levels of certain hormones. Participants will also be asked to complete questionnaires at study entry and at Week 12; the questionnaires will assess depression, stress, self-absorption, optimism, food cravings, hunger, the degree to which participants seek pleasure from activities, and participants' thoughts about their ability to make behavioral changes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University General Clinical Research Center
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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:
- Body mass index (BMI) between 30 and 45
- Live in the Portland, Oregon metropolitan area
- Willing and able to complete a 12-week weight loss program
- Meet at least 3 of the following 5 criteria: 1) waist circumference greater than 40 inches for men and 35 inches for women; 2) fasting triglycerides higher than 150 mg/dl; 3) high density lipoprotein (HDL) lower than 40 mg/dl for men and 50 mg/dl for women; 4) systolic blood pressure (BP) of 130 mmHg or higher or diastolic BP of 85 mmHg or higher; 5) fasting glucose of 100 mg/dl or higher
Exclusion Criteria:
- Any medications, including dietary supplements, that could interfere with the study
- Medical conditions contraindicating a diet and exercise weight loss program
- History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic cardiovascular disease
- Current diagnosis of cancer
- Hospitalization for a psychiatric condition within 12 months prior to study entry
- Weight loss medications within 6 months prior to study entry
- Change in body weight greater than 5% within 6 months prior to study entry
- Consumption of more than 21 alcoholic drinks per week
- Current participation in another clinical trial OR living in the same household with another participant in this study
- Currently exercising for more than 30 minutes, 3 times per week
- Fasting blood glucose higher than 125 mg/dl
- BP higher than 145/90
- Triglycerides higher than 500 mg/dl
- Training as a health care provider or health scientist
- Pregnancy or breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1
Has 100% expectation of receiving supplement
|
The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
Hour and a half weight loss education session weekly for 12 weeks.
|
|
Comparador falso: 2
Has 50% expectation of receiving supplement
|
The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.
Hour and a half weight loss education session weekly for 12 weeks.
|
|
Otro: 3
Has 0% expectation of receiving supplement.
|
Hour and a half weight loss education session weekly for 12 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cholesterol
Periodo de tiempo: baseline (Week 1) and outcome (Week 12)
|
baseline (Week 1) and outcome (Week 12)
|
|
insulin function
Periodo de tiempo: baseline (Week 1) and outcome (Week 12)
|
baseline (Week 1) and outcome (Week 12)
|
|
weight loss
Periodo de tiempo: baseline (Week 1) and outcome (Week 12)
|
baseline (Week 1) and outcome (Week 12)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cortisol levels
Periodo de tiempo: baseline (Week 1) and outcome (Week 12)
|
baseline (Week 1) and outcome (Week 12)
|
Colaboradores e Investigadores
Patrocinador
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
- U19AT002656 (Subvención/contrato del NIH de EE. UU.)
- U19AT002656-03 (Subvención/contrato del NIH de EE. UU.)
- U19AT002656-02 (Subvención/contrato del NIH de EE. UU.)
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