Topic: Metabolic and endocrine disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Body mass index (BMI) of 20-35 kg/m2 2. Age between 18-65 years (inclusive)
Exclusion criteria
Exclusion criteria: 1. Weight change of = 3kg in the preceding 2 months 2. Current smokers 3. Substance abuse 4. Excess alcohol intake 5. Pregnancy 6. Diabetes 7. Cardiovascular disease 8. Cancer 9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 10. Kidney disease 11. Liver disease 12. Pancreatitis 13. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 04/07/2016: Beta-cell function assessed by intravenous glucose tolerance test pre- and post 28 day intervention Previous primary outcome measures: Improvement in insulin sensitivity; Timepoint(s): 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 04/07/2016: 1. Glucose and insulin responses assessed by meal tolerance test pre- and post 28 day intervention 2. Gastric emptying assessed by 13C ocatnoic breath test pre- and post 28 day intervention 3. Gut microbiota composition assessed from a stool sample pre- and post 28 day intervention | — |
Countries
England, United Kingdom