- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02215603
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Fabiana Benatti
- Telefonnummer: +45 35450898
- E-Mail: fabiana.braga.benatti@regionh.dk
Studienorte
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Copenhagen, Dänemark, 2100
- Rekrutierung
- Centre of Inflammation and Metabolism
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Kontakt:
- Inge Holm
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Hauptermittler:
- Bente Pedersen, PhD
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Unterermittler:
- Fabiana Benatti, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Exclusion Criteria:
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
- evidence of thyroid, liver, lung, heart or kidney disease,
- non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
- VO2max levels above the considered average fitness according to age,
- contraindication to increased levels of physical activity.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Prolonged sitting
9 h of prolonged sitting
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Experimental: Prolonged sitting + interval standing bouts
Stand bout for 15-min every 30 minutes during the 9 hours of sitting
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Experimental: Moderate exercise bout + Prolonged sitting
30-min moderate-intensity exercise bout followed by 8 h of sitting
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Experimental: Moderate exercise bout + Prolonged sitting +Standing bouts
30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Area under the curve of glucose and insulin postprandial responses
Zeitfenster: 27 h
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Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Glucose levels
Zeitfenster: 27 hours
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Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours.
Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
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27 hours
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Area under the curve of lipid postprandial responses
Zeitfenster: 27 h
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Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Area under the curve of cytokine postprandial responses
Zeitfenster: 27 h
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Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- ProlongedSitting
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