- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Glasgow, Zjednoczone Królestwo, G312ER
- Rekrutacyjny
- School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
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Kontakt:
- Eleni Rizou, BSc MSc
- E-mail: e.rizou.1@research.gla.ac.uk
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Kontakt:
- Konstantinos Gerasimidis, BSc MSc PhD
- E-mail: Konstantinos.Gerasimidis@glasgow.ac.uk
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Exercise
4-week moderate intensity exercise programme
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4-week moderate intensity exercise programme
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Brak interwencji: Control
4 weeks of habitual life style
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Gut microbiota composition
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Interleukin-6 (IL-6)
Ramy czasowe: 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
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Glucose
Ramy czasowe: 3 months
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Changes in fasting glucose pre- and post-interventions measured by Randox Glucose
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3 months
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Triglycerides
Ramy czasowe: 3 months
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Changes in fasting and postprandial triglycerides pre- and post-interventions measured by Randox Triglycerides
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3 months
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Insulin
Ramy czasowe: 3 months
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Changes in fasting insulin pre- and post-interventions measured by Mercodia Insulin ELISA
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3 months
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Peptide YY (PYY)
Ramy czasowe: 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)
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12 months
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Glucagon-like peptide-1 (GLP-1)
Ramy czasowe: 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)
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12 months
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Subjective appetite
Ramy czasowe: 12 months
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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
Ramy czasowe: 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
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Faecal pH
Ramy czasowe: 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
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Body weight
Ramy czasowe: 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
Ramy czasowe: 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
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Body fat (kilograms)
Ramy czasowe: 1 month
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Differences in body fat expressed in kilograms between pre- and post-intervention measured by TANITA scales (TBF-300)
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1 month
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Body fat (% percentage)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Konstantinos Gerasimidis, BSc MSc PhD, University of Glasgow
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 200140132
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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