Comidas ricas en PROTeINA para controlar la glucosa (PROTIME)
Estrategias basadas en el horario de las comidas para mejorar el metabolismo de la glucosa en la prediabetes y la diabetes tipo 2
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Potsdam-Rehbrücke
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Potsdam, Potsdam-Rehbrücke, Alemania, 14558
- Olga Ramich
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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:
- Prediabetes (fasting blood sugar 100-125 mg/dl)
- Diabetes type 2 (fasting blood sugar >126 mg/dl)
- Overweight and obesity (BMI 25-50 kg/m2)
Exclusion Criteria:
- Other diabetes types
- Insulin treatment
- Shift work
- Weight changes >5% within past 3 months
- Systemic glucocorticoid therapy
- Systemic infections
- Severe anemia
- High blood pressure (>180/110 mmHg)
- Endocrinologic, liver and heart disorders
- Immune diseases
- Thyroid dysfunction
- Heart attack or stroke
- Cancer in the last 2 years
- Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
- Hereditary or acquired coagulation disorders
- Non-interruptible intake of blood thinners (anticoagulants)
- Specific diets, intermittent fasting
- Pregnancy or breastfeeding
- Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HP/HC - HC/HP
Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention. |
The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat. |
|
Experimental: HC/HP - HP/HC
Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention. |
The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean 24-hour glucose
Periodo de tiempo: 4 weeks
|
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM) |
4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of height
Periodo de tiempo: 4 weeks
|
Height measured by stadiometer |
4 weeks
|
|
Measurement of body weight
Periodo de tiempo: 4 weeks
|
Body weight measured by body scale |
4 weeks
|
|
Waist and hip circumference / waist to hip ratio
Periodo de tiempo: 4 weeks
|
Waist and hip circumference measured by tape measure |
4 weeks
|
|
Systolic and diastolic blood pressure
Periodo de tiempo: 4 weeks
|
Systolic and diastolic blood pressure changes measurement by manometer |
4 weeks
|
|
Body fat and lean mass
Periodo de tiempo: 4 weeks
|
Body fat and lean mass assessed by bioelectrical impendance analysis (BIA) |
4 weeks
|
|
Energy expenditure and substrate oxidation rates
Periodo de tiempo: 4 weeks
|
Energy expenditure and substrate oxidation rates assessed by indirect calorimetry |
4 weeks
|
|
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
Periodo de tiempo: 4 weeks
|
GGT, AST, ALT etermined in fasting blood samples |
4 weeks
|
|
Renal values (creatinine, urea, uric acid)
Periodo de tiempo: 4 weeks
|
Renal values determined in fasting blood samples |
4 weeks
|
|
Intra- und inter-day glycemic variability
Periodo de tiempo: 4 weeks
|
Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM) |
4 weeks
|
|
Glucose levels in meal tolerance test (MTT)
Periodo de tiempo: 4 weeks
|
Glucose levels in blood samples collected in MTT |
4 weeks
|
|
Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)
Periodo de tiempo: 4 weeks
|
Blood levels of metabolic hormones assessed in fasting state and during the MTT |
4 weeks
|
|
Inflammatory markers and T cell populations analyses
Periodo de tiempo: 4 weeks
|
Level of the inflammatory markers IL-6, TNFa, MCP-1 and T cell populations in circulation and adipose tissue are assessed through blood analysis and fat biopsy |
4 weeks
|
|
Satiety and hunger scores
Periodo de tiempo: 4 weeks
|
Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger) |
4 weeks
|
|
Sleep/wake timing and sleep quality
Periodo de tiempo: 4 weeks
|
Sleep/wake timing and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device |
4 weeks
|
|
Physical activity
Periodo de tiempo: 4 weeks
|
24-h physical activity will be monitored by an ActiGraph device |
4 weeks
|
|
Adipose tissue transcriptome
Periodo de tiempo: 4 weeks
|
RNA-Seq analysis of subcutaneous adipose tissue sample |
4 weeks
|
|
Gene expression in peripheral blood mononuclear cells (PBMC)
Periodo de tiempo: 4 weeks
|
Expression of metabolic genes assessed by qPCR |
4 weeks
|
|
Gut microbiota and microbiome-derived metabolites
Periodo de tiempo: 4 weeks
|
Determined in stool samples and blood plasma |
4 weeks
|
|
Determination of decision behavior
Periodo de tiempo: 4 weeks
|
Impulsiveness assessed by decision making tasks on computer |
4 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Olga Ramich, PD Dr., German Institute of Human Nutrition
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Diabetes Mellitus, Tipo 2
- Estado prediabético
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Fenómenos fisiológicos nutricionales
- Dieta
Otros números de identificación del estudio
- 90/2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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