Egg Yolk and Underlying Metabolisms on Modifying HDL Levels in Individuals With Metabolic Syndrome
Egg Yolk and Underlying Metabolisms on Modifying HDL Levels and Associated Genetics in Individuals With Metabolic Syndrome
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bangkok
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Bangkok Noi, Bangkok, Tailandia, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- weight stable > 3 months (changing < 5%)
- three or more of the following five criteria are met 2.1 waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) 2.2 fasting blood sugar ≥ 100 mg/dl 2.3 fasting triglyceride (TG) level ≥ 150 mg/dl 2.4 fasting high-density lipoprotein (HDL) cholesterol level ≤ 40 mg/dl (men) or ≤ 50 mg/dl (women) 2.5 blood pressure over 130/85 mmHg
- can consume food that provided in project
- healthy
Exclusion Criteria:
- consume drugs i.e. weight loss drugs, herbal pills, asthma drugs, steroid drugs, thyroid drugs, insulin injections, SGLT1 inhibitors drugs, SGLT2 inhibitors drugs, sulfonylurea drugs, blood lipid-lowering drugs
- people who exercise vigorously (> 150 minutes per week)
- people who are or have weight loss by consuming less than 30% of carbohydrates, or are losing weight by other methods or who have eaten a specific diet as prescribed by a doctor within the past 6 months
- people who drink alcohol more than once a week
- people who had a LDL level within 6 months > 190 mg/dl
- fasting blood glucose levels > 250 mg/dl and using diabetes drugs other than metformin
- people with heart disease, type 1 diabetes, renal impairment > level 3A
- history of cancer, lung disease, gastrointestinal disease
- people who smoke, people with eating disorder, people who have received psychiatric drugs
- become a volunteer in a research project that is conducting a study related to food consumption
- people who are unable to keep up with the treatment or are expected to be absent in this area for the next 4 months
- pregnancy or breastfeeding
- egg allergy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Yolk ketogenic diet
consume carbohydrate < 10% and 3 whole eggs supplement per day in 12 weeks
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Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
Experimental: White ketogenic diet
consume carbohydrate < 10% and 6 white eggs supplement per day in 12 weeks
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
|
Comparador activo: Control group
decrease consumption of diet from typical (decreased energy 20%) but consume carbohydrate in normal level
|
Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in weight following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
weight (kg) analysis
|
Baseline and after 12 weeks
|
|
Changes in body mass index following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
body mass index (kg/m^2) analysis
|
Baseline and after 12 weeks
|
|
Changes in waist circumference following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
waist circumference (cm) analysis
|
Baseline and after 12 weeks
|
|
Changes in lipid profiles concentration following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-cholesterol (mg/dl) and LDL-cholesterol (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in blood glucose and insulin concentration following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
HbA1C (%), glucose (mg/dl) and insulin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in betahydroxybutirate concentration following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
betahydroxybutirate (mmol/L) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in electrolytes concentration following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
Na+ (mg/dl), K+ (mg/dl), Cl- (mg/dl) and HCO3- (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in physical activity
Periodo de tiempo: Baseline and after 12 weeks
|
physical activity (MET-minutes/week) collect data by using questionnaires
|
Baseline and after 12 weeks
|
|
Change from baseline Glycemia at 180 minutes
Periodo de tiempo: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
glucose (mg/dl)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
|
Change from baseline Insulin at 180 minutes
Periodo de tiempo: Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
insulin (μU/ml)
|
Minutes after intake of 75 g glucose: 0, 30, 60, 90, 120, 180
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in blood pressure
Periodo de tiempo: Baseline and after 12 weeks
|
systolic and diastolic blood pressure (mmHg)
|
Baseline and after 12 weeks
|
|
Changes in fasting leptin levels
Periodo de tiempo: Baseline and after 12 weeks
|
leptin (mg/dl) concentration analysis
|
Baseline and after 12 weeks
|
|
Changes in energy intake following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
energy (kcal)
|
Baseline and after 12 weeks
|
|
Changes in carbohydrate following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
carbohydrate (g)
|
Baseline and after 12 weeks
|
|
Changes in protein intake following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
protein (g)
|
Baseline and after 12 weeks
|
|
Changes in fat intake following dietary intervention
Periodo de tiempo: Baseline and after 12 weeks
|
fat (g)
|
Baseline and after 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- MU-CIRB 2019/255.0310
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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