- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Carel le Roux
- Telefonnummer: +353864117842
- E-post: carel.leroux@ucd.ie
Studiesteder
-
-
-
Dublin, Irland, Dublin 4
- Rekruttering
- Clinical Research Centre
-
Ta kontakt med:
- Carel le Roux
- Telefonnummer: +353864117842
- E-post: carel.leroux@ucd.ie
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Microencapsulated fat stomach
Participants will consume a drink containing 400kcal of microencapsulated fat that will be released in the stomach.
|
Consumption of a drink that contains microencapsulated fat that will be released either in the stomach or in the distal small intestines.
|
Eksperimentell: Microencapsulated fat intestine
Participants will consume a drink containing 400kcal of microencapsulated fat that will be released in the intestine.
|
Consumption of a drink that contains microencapsulated fat that will be released either in the stomach or in the distal small intestines.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Completed bowel motion
Tidsramme: 24 hours
|
Proportion of participants reporting a completed bowel motion within 24 hours.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hunger
Tidsramme: 6 hours
|
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.
|
6 hours
|
calories
Tidsramme: 6 hours
|
Number of calories consumed during an ad libitum meal
|
6 hours
|
Gut hormones
Tidsramme: 6 hours
|
Gut hormones concentration
|
6 hours
|
Fullness
Tidsramme: 6 hours
|
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
|
6 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Carel le Roux, University College Dublin
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RS21-058
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Fat Microcapsules
-
Midwest Heart & Vascular SpecialistsRekrutteringAL Amyloidose | Amyloid | Hjerte amyloidose | Amyloidose Hjerte | Systemisk amyloidose | ATTR Amyloidosis villtype | Infiltrativ kardiomyopati, amyloidForente stater
-
EMO Biomedicine CorporationFar Eastern Memorial HospitalFullført
-
Riphah International UniversityRekrutteringMuskelstrammingPakistan
-
University of CadizInstituto de investigación e innovación biomédica de CádizRekrutteringDiabetes mellitus, type 2Spania
-
University of AarhusRanders Municipality, Denmark; Aarhus KommuneFullført
-
Universidade PositivoFullført
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI); Arizona Pharmaceuticals...Fullført
-
Zhujiang HospitalThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... og andre samarbeidspartnereRekrutteringKneartrose | Artropati av kneKina
-
Cairo UniversityHar ikke rekruttert ennå
-
University Psychiatric Clinics BaselHar ikke rekruttert ennåDepressiv lidelse | Major depressiv lidelse | Depresjon, bipolar