Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The obesity epidemic is well documented, and despite a complex etiology influenced by genetic, physiological, psychological, social, behavioral, and environmental factors, obesity seems to be the result of energy imbalance, where energy intake exceeds energy expenditure, regardless of the internal and external influences. Studies aiming to quantify and manipulate modulators of energy balance, including gastrointestinal (GI) energy absorption rates (i.e., digestibility), are crucial for reducing the incidence of overweight and obesity and improving overall human health. Despite considerable interindividual variability in the amount of ingested energy that is absorbed (~87-98% of ingested energy) by the gastrointestinal tract, generalized equations are used to calculate individual energy intake requirements, and the factors that contribute to such variability, including meal-timing, are largely unknown.
The proposed study seeks to determine the effects of restricting the eating window to 6-h (early time-restricted eating) as compared to a control eating window of 12 h on energy and macronutrient digestibility, thermic effect of food (TEF), postprandial blood metabolites (triglyceride, insulin, glucose, fructose, galactose, inositol, and sorbitol), 24 h glucose concentrations and glycemic variability, intestinal hydrogen gas production, microbiome composition, and gastrointestinal transit time in response to a controlled, energy balanced diet. In addition, this project will determine whether energy digestibility can be predicted from biological and physiological factors such as gut microbiota composition, gastrointestinal transit time, 24-h glucose concentrations, and postabsorptive and postprandial metabolomic profiles.
Participants will be randomized to early TRE (6-h feeding window, 8am-2pm) or a control eating schedule (12-h feeding window, 8am-8pm) and consume a controlled, energy balance diet (breakfast, lunch, dinner, snacks, and beverages) for 9 consecutive days before crossing over to the other intervention after at least a 3-wk washout for females (to control for hormonal fluctuations) and at least a 2-wk washout for males. Participants will collect stool and urine during each feeding phase. Gross energy content (heat combustion by bomb calorimetry) of the diet, stool, and urine samples will be used to calculate energy digestibility (diet gross energy - stool gross energy) and metabolizable energy. Factors that may mediate and/or predict energy digestibility efficiency, including gastrointestinal microbial composition, transit time, and gas production, fasting and postprandial metabolites, continuous glucose concentrations, and thermogenesis will be assessed.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Florida
-
Tallahassee, Florida, Estados Unidos, 32306
- Florida State University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 20-45 years old
- Normal weight or overweight (18.5 to 29.9 kg/m2)
- Not taking any probiotics for 4 weeks prior to and throughout the entire study
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the study
- Willing to consume a controlled diet for 9 consecutive days on 2 different occasions (18 days total) and collect all urine and fecal output for 3-5 days during each occasion
- Pass the blue dye gastrointestinal tracer (given at screening) within 72 hours of administration
Exclusion Criteria:
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders, prior bariatric surgery, malabsorption, or any condition that interferes with metabolism (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Suspected or known strictures, fistulas, or physiological/mechanical gastrointestinal obstruction
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Women who are pregnant, lactating, planning to become pregnant, or who have an irregular menstrual cycle in the past 6 months
- Weight fluctuations ± 5% of body weight in the last 6 months
- Allergies or intolerance to foods included in the controlled diet
- Any use of antibiotics, except topical antibiotics, within 3 months of study participation
- Colonoscopy within 3 months of study participation
- Use of laxatives, stool softeners, or anti-diarrheal medications more than once a week within 4-weeks of study enrollment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: early time-restricted eating (eTRE)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 6-h window in the morning hours (e.g., 8:00 AM - 2:00 PM)
|
A diet meeting the participant's weight maintenance energy needs will be provided.
|
|
Experimental: control eating schedule (CON)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 12-h window in the morning hours (e.g., 8:00 AM - 8:00 PM)
|
A diet meeting the participant's weight maintenance energy needs will be provided.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Energy digestibility
Prazo: Days 4-9
|
Calculated as gross energy of the diet (kcals) - gross energy excreted in stool (kcals)
|
Days 4-9
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fat digestibility
Prazo: Days 4-9
|
Calculated as fat content of the diet - fat content excreted in stool
|
Days 4-9
|
|
Carbohydrate digestibility
Prazo: Days 4-9
|
Calculated as carbohydrate content of the diet - carbohydrate content excreted in stool
|
Days 4-9
|
|
Protein digestibility
Prazo: Days 4-9
|
Calculated as protein content of the diet - protein content excreted in stool
|
Days 4-9
|
|
Metabolizable energy
Prazo: Days 4-9
|
Calculated as gross energy of the diet (kcals) - gross energy excreted in urine and stool (kcals)
|
Days 4-9
|
|
Metabolizable protein
Prazo: Days 4-9
|
Calculated as protein content of the diet - protein excreted in urine and stool
|
Days 4-9
|
|
Postabsorptive and postprandial plasma metabolites
Prazo: Day 6
|
Plasma metabolites will be measured using gas chromatography coupled with mass spectrometry in the postabsorptive state and following a standardized meal (1 hour, 2 hours, 3 hours, and 4 hours after meal intake).
|
Day 6
|
|
Gut microbiome
Prazo: Day 6
|
Microbiota composition and diversity will be determined using 16S rRNA gene sequencing.
|
Day 6
|
|
Gastrointestinal transit time
Prazo: Day 6
|
A gas-sensing capsule will be ingested to measure transit time in the gastrointestinal tract.
|
Day 6
|
|
Gastrointestinal gas production
Prazo: Day 6
|
A gas-sensing capsule will be ingested to measure hydrogen, carbon dioxide, and oxygen production in the gastrointestinal tract.
|
Day 6
|
|
Gastrointestinal temperature
Prazo: Day 6
|
A gas-sensing capsule will be ingested to measure temperature in the gastrointestinal tract.
|
Day 6
|
|
24-h glucose concentrations
Prazo: Days 1-8
|
A continuous glucose monitor will be used to collect and assess 24-h glucose concentrations.
|
Days 1-8
|
|
24-h glucose variability
Prazo: Days 1-8
|
A continuous glucose monitor will be used to collect and assess 24-h glucose variability.
|
Days 1-8
|
|
Thermic effect of food
Prazo: Day 6
|
Indirect calorimetry measures will be collected in the resting state and for 4 hours (15-30, 45-60, 75-90, 105-120, 165-180, and 225-240 minutes) following the consumption of a standardized meal.
|
Day 6
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Claire E Berryman, Ph.D., Florida State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- STUDY00001564
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .