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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, Tyskland, 14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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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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Aktiv 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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change in release of GIP
Tidsramme: 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
Tidsramme: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GLP-1 between the two interventions
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4 weeks (cross-over)
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change in release of GLP-2
Tidsramme: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GLP-2 between the two interventions
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4 weeks (cross-over)
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change in release of PYY
Tidsramme: 4 weeks (cross-over)
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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
Tidsramme: 4 weeks (cross-over)
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change in fasting state and post-glucose release of insulin between the two interventions
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4 weeks (cross-over)
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Tidsramme: 4 weeks (cross-over)
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change in fasting state and post-glucose insulin secretion between the two interventions
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4 weeks (cross-over)
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Tidsramme: 4 weeks (cross-over)
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change in fasting state and post-glucose insulin sensitivity between the two interventions
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4 weeks (cross-over)
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ILIAS-2
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