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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ILIAS-2
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