- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05324241
Laxative Properties of Microencapsulated Lipid (Constipation Study)
A Proof of Principle Study of the Laxative Properties of Microencapsulated Lipid in Patients Experiencing Constipation Related to Intentional Weight Loss
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Chronic constipation most frequently arises as a functional disorder of at least 3 months duration, the aetiology of which is multifactorial encompassing dietary and lifestyle factors arising in the context of intact colonic motility. Confirmatory clinical diagnosis of chronic constipation under this definition can be made with reference to the Rome IV criteria encompassing assessment of stool frequency, quality, straining etc.
Whilst broadly prevalent across the population, constipation is particularly troublesome in a significant number of patients undergoing interventions for weight loss in obesity, be that dietary, pharmacological or surgical. Calorie restriction per se, which is a common feature of most interventions for obesity necessarily reduces stimulation of colonic motility by impacting the frequency and intensity of colonic mass movements. Moreover, decreases in dietary fibre during food restriction result in debulking of the stool.
Multiple dietary and pharmacological approaches to the management of chronic constipation are available to mitigate the risk of constipation during weight loss and treat it when it becomes manifest. However, these can often be poorly accepted due to gastrointestinal side effects. Interestingly, the potential laxative properties of orlistat, a pancreatic lipase inhibitor-based treatment for morbid obesity have been investigated in off-label studies in the setting of idiopathic chronic constipation and constipation associated with opioid pain medication and anti-psychotic (clozapine) therapy. Mechanism of action in these cases most probably relates to the pro-kinetic and lubricatory effects of the increasing passage of undigested fat to the colon. Based on these case series, the potential for weight loss pharmacotherapy with in-built mitigation of associated constipation becomes an attractive concept.
When digestive and absorptive processes are impeded or moved distally in the small intestine, as can happen with respect to dietary triglycerides during orlistat therapy, satiety gut hormone signal and quantity of food intake are affected. During an ileal infusion of a lipid emulsion, healthy subjects ate a smaller amount compared to control infusions. A study in healthy volunteers in which fat was delivered via a nasal tube to the duodenum, jejunum and ileum found that the ileal treatment had the most pronounced effect on food intake and satiety.
The investigators have used a new food encapsulation technology using natural food grade pea protein, AnaBio©*, to deliver pure oleic acid to the distal small intestine showed significant attenuation of food intake in association with enhancement of enteroendocrine satiety hormone release. The results recorded an increase in the number of bowel motions over the subsequent 24 hours in half of the participants. Subsequently, the investigators showed that ingestion of a smaller 400kcal cargo of microencapsulated oleic acid resulted in decreased hunger and food intake, no increase in the frequency of bowel motion but an increase in stool softness.
Based on the above data the investigators are encouraged to proceed with the present study, the main goal of which is therefore to investigate whether the 400kcal dose of encapsulated fat delivered to the distal small intestine might be a useful supportive therapy in patients engaged in intensive weight loss therapies and experiencing constipation as a consequence.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Carel le Roux
- Numéro de téléphone: +353864117842
- E-mail: carel.leroux@ucd.ie
Lieux d'étude
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Dublin, Irlande, Dublin 4
- Recrutement
- Clinical Research Centre
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Contact:
- Carel le Roux
- Numéro de téléphone: +353864117842
- E-mail: carel.leroux@ucd.ie
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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:
- 18-65 years
- Engaged in weight loss treatment
- Diagnosis of chronic constipation (Rome IV criteria)1
- Capacity to consent to participate
Exclusion Criteria:
- Substance abuse
- Pregnancy
- Patients who are taking medication for constipation should be on stable doses of medications for constipation for more than 2 weeks. They should neither start nor stop any medication for constipation in the 2 weeks prior to the visits.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Microencapsulated fat stomach
Participants will consume a drink containing 400kcal of microencapsulated fat that will be released in the stomach.
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Consumption of a drink that contains microencapsulated fat that will be released either in the stomach or in the distal small intestines.
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Expérimental: Microencapsulated fat intestine
Participants will consume a drink containing 400kcal of microencapsulated fat that will be released in the intestine.
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Consumption of a drink that contains microencapsulated fat that will be released either in the stomach or in the distal small intestines.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Completed bowel motion
Délai: 24 hours
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Proportion of participants reporting a completed bowel motion within 24 hours.
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24 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hunger
Délai: 6 hours
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Hunger scores as measured by Visual Analogue Scales, the scale has a score from 0 to 100 with 0 being least hungry and 100 being most hungry.
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6 hours
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calories
Délai: 6 hours
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Number of calories consumed during an ad libitum meal
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6 hours
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Gut hormones
Délai: 6 hours
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Gut hormones concentration
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6 hours
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Fullness
Délai: 6 hours
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Fullness scores as measured by Visual Analogue Scales, the scale has a score from 0 to 100 with 0 being least full and 100 being most full
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6 hours
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Carel le Roux, University College Dublin
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RS21-058
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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