Topic: Primary Care, Metabolic and endocrine disorders
Conditions
Interventions
Study 1: Cellulose, Control
Inulin, Control
Inulin-propionate ester, Inulin-propionate ester
Study Entry : Single Randomisation only
Added 24/01/2018:
Study 2: Inulin, Control
Study Entry : Single Randomisation only
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study 1: 1. Healthy volunteers aged 18-65 2. Male or female 3. Body mass index (weight in kg divided by height in metre squared) of 25-40 kg/m2 Added 24/01/2018: Study 2: 1. Male or female aged 18-65 years 2. Body mass index (weight in kg divided by height in metre squared) of BMI of 20-40 kg/m2 3. Histological confirmation of NAFLD in previous 5 years. 4. Controlled blood glucose levels (HbA1c <48 mmol/mol)
Exclusion criteria
Exclusion criteria: Study 1 and Study 2: 1. Weight change of more than 3kg in the preceding 3 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 including: antiinflammatory drugs or steroids, androgens, phenytoin, erythromycin or thyroid hormones Study 2 has the additional exclusion criteria: 14.? Metallic or magnetic implants such as pacemakers ?15. Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1: Glucose homeostasis; Timepoint(s): End of each 6 week intervention Added 24/01/2018: Study 2: Intrahepatocellular lipid content | — |
Secondary
| Measure | Time frame |
|---|---|
| Study 1: Body composition; Timepoint(s): End of each 6 week intervention | — |
Countries
United Kingdom
Outcome results
None listed