Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
21 de setembro de 2021 atualizado por: Yanna Zhu, Sun Yat-sen University
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders.
The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions.
A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function.
While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks.
Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function.
Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear.
More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function.
Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yanna Zhu, M.D
- Número de telefone: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
Estude backup de contato
- Nome: Ying Ding, M.M
- Número de telefone: 86-20-87335573
- E-mail: dingy69@mail.sysu.edu.cn
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Recrutamento
- Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yatsen University
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Contato:
- Yanna Zhu, M.D
- Número de telefone: 86-20-87330663
- E-mail: zhuyn3@mail.sysu.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
17 anos a 24 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m^2.
- Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
- Having the time and volunteering to receive the interventions.
Exclusion Criteria:
- Currently engaged in other weight-loss studies.
- With high blood pressure, diabetes or other cardiovascular diseases.
- With secondary obesity induced by medicine or other diseases.
- Contraindication to exercise.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
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Exercício de pular corda três vezes por semana (90 minutos de cada vez, com intervalo de 10 minutos após 20 minutos de pular corda).
Pulseira de exercício e pulseira inteligente seriam usadas para registrar o consumo de energia ao longo do estudo.
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Experimental: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
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Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Experimental: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
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Exercício de pular corda três vezes por semana (90 minutos de cada vez, com intervalo de 10 minutos após 20 minutos de pular corda).
Pulseira de exercício e pulseira inteligente seriam usadas para registrar o consumo de energia ao longo do estudo.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
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Sem intervenção: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body weight
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Body weight change of participants
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body fat percentage
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Body fat percentage were measured by body composition analyzers.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fat mass
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fat mass (in kg) were measured by body composition analyzers.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Systolic and diastolic blood pressure
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124).
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Serum lipid levels
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose were analyzed by the glucose oxidase method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma insulin
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Fasting plasma glucose were analyzed by the electrochemiluminescence method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Intestinal flora
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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To measure the change of intestinal flora by analyzing feces genome 16S rDNA.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The executive functions were measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Form.
Items are rated 1 (never), 2 (sometimes), and 3 (often).
There is no range for a total score.
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Change in appetite sensations
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The appetite sensations were measured by the visual analogue scale (VAS).The VAS consisted of 100-mm lines and participants were required to place a vertical mark across the line corresponding best to their feelings of hunger, satisfaction, and fullness, with the scale ranging from 0 (not at all) to 100 (extremely).
Quantification was performed by measuring the distance between the left end of the line and the vertical mark.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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High-Sensitivity C-Reactive Protein (hs-CRP)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Intercellular adhesion molecule-1 (ICAM-1)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Tumor necrosis factor alpha (TNF-alpha)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Chemokine CCL2
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Vascular cell adhesion molecule (VCAM-1)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Interleukin-6 (IL-6)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Interleukin-8 (IL-8)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Leptin
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Tau protein
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Brain-derived neurotrophic factor (BDNF)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Vascular endothelial growth factor (VEGF)
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Circulating metabolome
Prazo: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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To measure the change of circulating metabolome by LC-MS/MS method.
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Baseline (1-2 days before the intervention), right after intervention (12 weeks)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yanna Zhu, M.D, Sun Yat-sen University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de abril de 2021
Conclusão Primária (Antecipado)
31 de dezembro de 2022
Conclusão do estudo (Antecipado)
28 de fevereiro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
3 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de abril de 2021
Primeira postagem (Real)
8 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ZDGW[2021]044
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .