Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 (ILIAS-2)
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, Deutschland, 14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
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Aktiver Komparator: Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
change in release of GIP
Zeitfenster: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GIP between the two interventions
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4 weeks (cross-over)
|
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change in release of GLP-1
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-1 between the two interventions
|
4 weeks (cross-over)
|
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change in release of GLP-2
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-2 between the two interventions
|
4 weeks (cross-over)
|
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change in release of PYY
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of PYY between the two interventions
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4 weeks (cross-over)
|
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change in release of insulin
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of insulin between the two interventions
|
4 weeks (cross-over)
|
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose insulin secretion between the two interventions
|
4 weeks (cross-over)
|
|
change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Zeitfenster: 4 weeks (cross-over)
|
change in fasting state and post-glucose insulin sensitivity between the two interventions
|
4 weeks (cross-over)
|
Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ILIAS-2
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