Obesity Digestive System
Conditions
Interventions
This is a randomised crossover study during which healthy volunteers are clinical research facility inpatients for four days on three separate occasions. On day one of the study, a naso-enteric tube i
Sponsors
Imperial College of Science, Technology and Medicine
Eligibility
Sex/Gender
All
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. Abnormal ECG 2. Screening blood results outside of normal reference values 3. Weight change of > = 5kg in the preceding 2 months 4. Current smokers 5. History of substance abuse and/or excess alcohol intake 6. Pregnancy 7. Diabetes 8. Cardiovascular disease 9. Cancer 10. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Metabolic profiling of ileal samples is measured using 1H NMR spectroscopy, ultra-performance LC-MS and GC-MS on Day 3 and Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 2. Microbiological profiling of ileal samples is measured using 16S sequencing on Day 3 and Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/09/2018: 1. Metabolic and hormonal profiling of blood samples is measured using radioimmunoassay, 1H NMR spectroscopy, ultra-performance LC-MS and GC-MS on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 2. Microbiological profiling of faecal samples is measured using 16S sequencing on each day of the 4-day study visit 3. Subjective appetite is measured using visual analogue scales on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 4. Nausea is measured using visual analogue scales on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 5. Metabolic profiling of faecal samples is measured using 1H NMR spectroscopy on each day of the intervention 6. Detection of plant structures, cell structures and starch granules in ileal samples is measured by microscopy on Day 3 and Day 4 of the intervention Previous secondary outcome measures: 1. Metabolic and hormonal profiling of blood samples is measured using radioimmunoassay, 1H NMR spectroscopy, ultra-performance LC-MS and GC-MS on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 2. Microbiological profiling of faecal samples is measured using 16S sequencing on each day of the 4-day study visit 3. Subjective appetite is measured using visual analogue scales on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast 4. Nausea is measured using visual analogue scales on Day 4 at baseline and 60, 120, 180, 240, 300, 360, 420 and 480 min following breakfast | — |
Countries
England, United Kingdom
Outcome results
None listed