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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, Allemagne, 14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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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Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
change in release of GIP
Délai: 4 weeks (cross-over)
|
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
Délai: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-1 between the two interventions
|
4 weeks (cross-over)
|
|
change in release of GLP-2
Délai: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of GLP-2 between the two interventions
|
4 weeks (cross-over)
|
|
change in release of PYY
Délai: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of PYY between the two interventions
|
4 weeks (cross-over)
|
|
change in release of insulin
Délai: 4 weeks (cross-over)
|
change in fasting state and post-glucose release of insulin between the two interventions
|
4 weeks (cross-over)
|
|
change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Délai: 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
Délai: 4 weeks (cross-over)
|
change in fasting state and post-glucose insulin sensitivity between the two interventions
|
4 weeks (cross-over)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ILIAS-2
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