Overweight adults with no known co-morbidities Nutritional, Metabolic, Endocrine
Conditions
Interventions
All subjects will undergo a screening visit. This will include an assessment of inclusion/exclusion criteria, physical exam, alcohol and substance screening test, pregnancy test for women and routine
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Being able to provide written informed consent 2. Age between 18 and 65 years 3. Body Mass Index (BMI) =25 kg/m² and 14 units/week) 10. Women of childbearing age must have a negative pregnancy test at screening and must not be breastfeeding 11. Women of childbearing age who are sexually active with a male partner must use highly effective contraceptive methods
Exclusion criteria
Exclusion criteria: 1. Use of any regular medications 2. Use of illicit drugs 3. Use of any over the counter supplements affecting metabolism 4. Diagnosis of any acute/chronic disease 5. Current smoking or excess alcohol consumption (>14 units/week) 6. Current pregnancy or lactation 7. Abnormal findings on physical exam or routine blood tests at screening (full blood count, urea and electrolytes, HbA1C, liver function tests) 8. Concurrent participation in another trial with an investigational product 9. History of anaphylaxis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Insulin sensitivity - expressed as M-value calculated from the hyperinsulinaemic euglycaemic clamp component of the Botnia clamp at visit 1 and visit 2 2. Insulin secretion - calculated from the frequently sampled intravenous glucose tolerance test component of the Botnia clamp at visit 1 and visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed