Investigating gut hormone and satiety responses Digestive System
Conditions
Interventions
15 healthy volunteers will attend a screening and a 3-day inpatient visit. During the main visit, two nasoenteric tubes will be inserted through nostrils into the ileum (day 1) and duodenum (day 2). T
randomisation will be performed using the 'sealed envelope' website by an independent researcher (i.e., not linked to the study):
• Intervention arm: Participants will consume an oral drink through a
Subjective appetite scores will be recorded
Urine samples will be collected to measure metabolite levels. After the infusion interventions, a pasta meal will be provided to measure food intake.
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age between 18-65 years (inclusive) 3. Body mass index (BMI) of 18-30 kg/m2 4. Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 2. Abnormal ECG 3. Screening blood results outside of normal reference values 4. Weight change of > = 5kg in the preceding 2 months 5. Current smokers 6. History of substance abuse and/or excess alcohol intake 7. Pregnancy 8. Diabetes 9. Cardiovascular disease 10. Cancer 11. Kidney disease 12. Liver disease 13. Pancreatitis 14. Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones. 15. Participation in a research study in the 12-week period prior to entering this study. 16. Any blood donation within the 12-week period prior to entering this study 17. Previous surgery on the bones inside the nose, or nasal airway obstruction Any participants with the above conditions would already have an altered pattern of hormones and inflammatory molecules because of their disease process and would therefore give us confounding or misleading results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of gut hormones including gastric inhibitory polypeptide (GIP), glucagon-like peptide-1 (GLP-1), peptide Y (PYY), cholecystokinin (CCK) and oxyntomodulin (OXM) are measured by enzyme-linked immunosorbent assay (ELISA) or radioimmunoassay (RIA) assays at -10, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Appetite is measured using the visual analogue score (VAS) at -10, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes 2. Food intake is measured using an ad libitum pasta meal immediately after the 0-180 min intervention period 3. Plasma glucose concentrations are measured using the glucose oxidase-peroxidase aminophenazone phenol (GOD-PAP) method at -10, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes 4. Serum insulin concentrations are measured using an ELISA method at -10, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes 5. Blood metabolites are measured using proton nuclear magnetic resonance profiling (1H NMR profiling) at -10, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes 6. Urine metabolites are measured using 1H NMR profiling on post-infusion samples (collected over 0-180min) | — |
Countries
England, United Kingdom
Contacts
Public ContactMingzhu Cai
Outcome results
None listed