- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03344133
Effect of Exercise Programme on Gut Microbiota, CVD Risk Factors and Appetite Regulation in Overweight Women
Effect of a 4-week Moderate Intensity Exercise Programme on Gut Microbiota, Cardiovascular Disease Risk Factors and Appetite Regulation in Overweight Women
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Design: This is a randomized controlled study with a parallel design. Healthy, sedentary females aged between 18-45 years old will be recruited by means of an advertisement leaflet and word of mouth. Eligible participants will be enrolled in the study and will be randomly allocated to either exercise intervention (EX) or control (C) groups. The EX group will participate in a 4-week exercise intervention and the C group will be asked to continue with habitual life style for 4 weeks. Before and after 4 weeks of the intervention, participants from both groups will be asked to conduct a submaximal exercise test and a 7-hour experimental trial during which blood samples will be collected and metabolic rate will measured before and after consumption of standardized breakfast and lunch. Prior to the first 7-hour trial, participants will be asked to record diet for 3 days and replicate this diet prior to the second 7-hour trial. During these 3 days participants will provide fresh stool samples. Participants allocated to control group will have the option to participate in exercise intervention. A subset of the participants will repeat a 7-hour experimental trial and provide fresh stool and urine sample after 7 days of detraining.
Methods:
Preliminary Health Check: Participants will undertake a health screening questionnaire on the day of recruitment. Participants will also need to fill in Physical Activity Readiness Questionnaire (PARQ). Only participants who answered "no" to all questions in PARQ will conduct the submaximal exercise test.
Anthropometry: All participants will have height, weight and waist circumference measured at baseline and 4 weeks after the intervention.
7-hour Experimental Trial: Participants will attend the metabolic suite (New Lister Building, Glasgow Royal infirmary) in a fasted state at approximately 9.00 am. Participants will be instructed to lie supine on the couch, with the head resting on the pillow provided. Resting metabolic rate will be measured for 20 minutes and fasting blood sample will be obtained. A breakfast meal will be consumed immediately after the fasting sample and a lunch meal after 4 hours. Blood samples will be taken throughout a cannula hourly after breakfast and lunch consumption. Following each blood sample, metabolic rate will be measured for the duration of 20 minutes. Prior each blood sample, participants will fill in appetite questionnaires. Blood samples will be analysed for plasma lipids, glucose, insulin, inflammatory markers and gut appetite hormones using standard existing procedures.
Feacal sample collection & analysis: A disposable stool sample collection kit will be provided prior to the 7-hour trial day. Once collected, the container is sealed and placed in a larger sealable bag with a reducing sachet to remove oxygen and maintain anaerobic bacteria. Stool samples will be measured for changes in gut microbiota based on 16S rRNA amplicon sequencing, bacterial functional capacity and targeted bacterial metabolites (short chain fatty acids, sulphide, ammonia).
Exercise Training Programme: Exercise training will consist of 4 weekly sessions of endurance type exercise (cycling and running) lasting for 30, 40, 50, 60 minutes in the week 1, 2, 3 and 4 respectively. The time and day of each training trial will be agreed between the investigator and the participant and will be based around the participant's availability. All exercise sessions will be supervised by a researcher.
Submaximal Exercise Test: Participants will exercise on treadmill at gradually increasing intensities until 85% of maximal heart rate. During the last minute of each of the intensities heart rate will be measured and expired air will be collected by Douglas bag technique and analysed for oxygen consumption and carbon dioxide production. Relation between heart rate and rate of oxygen consumption will be used to predict maximal oxygen consumption, a marker of cardio-respiratory fitness.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Glasgow, Reino Unido, G312ER
- Recrutamento
- School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
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Contato:
- Eleni Rizou, BSc MSc
- E-mail: e.rizou.1@research.gla.ac.uk
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Contato:
- Konstantinos Gerasimidis, BSc MSc PhD
- E-mail: Konstantinos.Gerasimidis@glasgow.ac.uk
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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:
- Healthy, sedentary females, BMI>25 kg/m2, on a stable body weight for the last 3 months
Exclusion Criteria:
- Acute or chronic illness, use of antibiotics the past 3 months, smoking
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Exercise
4-week moderate intensity exercise programme
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4-week moderate intensity exercise programme
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Sem intervenção: Control
4 weeks of habitual life style
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Gut microbiota composition
Prazo: 12 months
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Changes in the gut microbiota composition measured by 16S rRNA amplicon sequencing.
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Interleukin-6 (IL-6)
Prazo: 3 months
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Changes in fasting and postprandial interleukin-6 pre- and post-interventions measured by Human IL-6 ELISA Ready-Set-Go (Affymetrix, eBioscience)
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3 months
|
Glucose
Prazo: 3 months
|
Changes in fasting glucose pre- and post-interventions measured by Randox Glucose
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3 months
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Triglycerides
Prazo: 3 months
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Changes in fasting and postprandial triglycerides pre- and post-interventions measured by Randox Triglycerides
|
3 months
|
Insulin
Prazo: 3 months
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Changes in fasting insulin pre- and post-interventions measured by Mercodia Insulin ELISA
|
3 months
|
Peptide YY (PYY)
Prazo: 12 months
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Changes in fasting and postprandial peptide YY pre- and post-interventions measured by Human PYY (Total) ELISA (Merc Millipore)
|
12 months
|
Glucagon-like peptide-1 (GLP-1)
Prazo: 12 months
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Changes in fasting and postprandial glucagon-like peptide-1 pre- and post-interventions measured by GLP-1 Total ELISA (Merc Millipore)
|
12 months
|
Subjective appetite
Prazo: 12 months
|
Changes in subjective appetite (hunger, satiety, fullness, prospective food consumption, desire to eat) pre- and post-interventions measured by Visual Analogue Scales (VAS) where respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (minimum score is 0 and maximum score is 100)
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12 months
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Faecal short-chain fatty acids
Prazo: 12 months
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Changes in concentrations of feacal short-chain fatty acids pre- and post-interventions measured by TRACE 2000 Gas Chromatography (ThermoQuest Ltd)
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12 months
|
Faecal pH
Prazo: 1 month
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Changes in feacal pH between pre- and post-intervention measured by Hanna HI 98140
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1 month
|
Body weight
Prazo: 1 month
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Differences in body weight (kilograms) between pre- and post-intervention measured by TANITA scales (TBF-300)
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1 month
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Height
Prazo: 1 month
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Height (meters) measured by stadiometer, a vertical ruler with a sliding horizontal paddle which is adjusted to rest on the top of the head
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1 month
|
Body fat (kilograms)
Prazo: 1 month
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Differences in body fat expressed in kilograms between pre- and post-intervention measured by TANITA scales (TBF-300)
|
1 month
|
Body fat (% percentage)
Prazo: 1 month
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Differences in body fat expressed as percentage (%) (proportion of fat to the total body weight) between pre- and post-intervention measured by TANITA scales (TBF-300)
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1 month
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Body Mass Index (BMI)
Prazo: 1 month
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Differences in body mass index (weight and height will be combined to report BMI in kg/m^2) between pre- and post-intervention measured by TANITA scales (TBF-300)
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1 month
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Dietary Intake
Prazo: 6 months
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Energy intake and macro nutrient intake using WinDiets software based on food composition tables
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6 months
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Maximum Oxygen Consumption
Prazo: 2 weeks
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Maximum Oxygen Consumption (ml/kg/min) measured before and after the interventions by Servomex Gas Analyser
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2 weeks
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Energy substrate oxidation
Prazo: 6 months
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Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (Oxycon Pro)
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6 months
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Resting Metabolic Rate
Prazo: 2 month
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Resting metabolic rate was measured before and after the interventions (Oxycon Pro)
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2 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Konstantinos Gerasimidis, BSc MSc PhD, University of Glasgow
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Outros números de identificação do estudo
- 200140132
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