Refeições ricas em PROTeIn para controlar a glicose (PROTIME)
Estratégias baseadas no horário das refeições para melhorar o metabolismo da glicose no pré-diabetes e no 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Potsdam-Rehbrücke
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Potsdam, Potsdam-Rehbrücke, Alemanha, 14558
- Olga Ramich
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean 24-hour glucose
Prazo: 4 weeks
|
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM) |
4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measurement of height
Prazo: 4 weeks
|
Height measured by stadiometer |
4 weeks
|
|
Measurement of body weight
Prazo: 4 weeks
|
Body weight measured by body scale |
4 weeks
|
|
Waist and hip circumference / waist to hip ratio
Prazo: 4 weeks
|
Waist and hip circumference measured by tape measure |
4 weeks
|
|
Systolic and diastolic blood pressure
Prazo: 4 weeks
|
Systolic and diastolic blood pressure changes measurement by manometer |
4 weeks
|
|
Body fat and lean mass
Prazo: 4 weeks
|
Body fat and lean mass assessed by bioelectrical impendance analysis (BIA) |
4 weeks
|
|
Energy expenditure and substrate oxidation rates
Prazo: 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))
Prazo: 4 weeks
|
GGT, AST, ALT etermined in fasting blood samples |
4 weeks
|
|
Renal values (creatinine, urea, uric acid)
Prazo: 4 weeks
|
Renal values determined in fasting blood samples |
4 weeks
|
|
Intra- und inter-day glycemic variability
Prazo: 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)
Prazo: 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)
Prazo: 4 weeks
|
Blood levels of metabolic hormones assessed in fasting state and during the MTT |
4 weeks
|
|
Inflammatory markers and T cell populations analyses
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 4 weeks
|
24-h physical activity will be monitored by an ActiGraph device |
4 weeks
|
|
Adipose tissue transcriptome
Prazo: 4 weeks
|
RNA-Seq analysis of subcutaneous adipose tissue sample |
4 weeks
|
|
Gene expression in peripheral blood mononuclear cells (PBMC)
Prazo: 4 weeks
|
Expression of metabolic genes assessed by qPCR |
4 weeks
|
|
Gut microbiota and microbiome-derived metabolites
Prazo: 4 weeks
|
Determined in stool samples and blood plasma |
4 weeks
|
|
Determination of decision behavior
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Diabetes Mellitus, Tipo 2
- Estado pré-diabético
- Dieta, comida e nutrição
- Fenômenos fisiológicos
- Fenômenos fisiológicos nutricionais
- Dieta
Outros números de identificação do estudo
- 90/2023
Plano para dados de participantes individuais (IPD)
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