Prevention of excessive weight and obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Current interventions as of 23/02/2024:
This is a multi-centre, interventional study evaluating the safety, feasibility and tolerability of Sirona hydrogel on a population of healthy male and female a
however, the researchers anticipate that the higher dosing of 12 ta
Sponsors
Oxford Medical Products
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged 18 to 65 years 2. Healthy volunteers 3. BMI 30-40 kg/m² 4. Be able to understand, read and write English 5. Should not be vegan (foods used in appetite measurements will be suited to vegetarians and meat-eaters) 6. Must be able to swallow a Sirona dummy tablet prior to enrolment on the study. Failure to swallow tablets will result in exclusion from the trial 7. Must pass the psychological evaluation (undertaken by a bariatric psychologist)
Exclusion criteria
Exclusion criteria: 1. Any oral medication being taken 2. People with known human immunodeficiency virus (HIV) Note: Adults with HIV not on oral anti-retroviral drugs may participate in this study if their BMI is between 30-40 kg/m² 3. Non-ambulatory 4. Hiatal hernia >3 cm 5. Positive for H. pylori 6. People with active gastric or duodenal ulcer disease 7. Previous gastric or oesophageal surgery 8. Severe oesophagitis 9. History of psychiatric disorders (OCD, depression, bulimia nervosa and anorexia nervosa) 10. Associated severe systemic disease not amenable to improvement with weight loss 11. People with inflammatory bowel diseases 12. People on anticoagulant treatment or steroids 13. Addiction to drugs or alcohol 14. People with gastric or oesophageal varices 15. Proton pump inhibitor (PPI) current usage 16. Pregnant or foreseeable pregnancy during the study or lactating females 17. People who smoke including cigarettes, pipes, cigars, hookahs and e-cigarettes 18. People who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures 19. People with contraindications for MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WP0: 1. The total number of reported Serious Adverse Events (SAEs) measured using throughout the study. All AEs observed by the Investigator or reported by the participant, whether or not attributed to Sirona, will be recorded in the eCRF by the study team with a full description including the nature, date and time of onset, determination of non-serious versus serious, severity (grades 1-5), causality (unrelated possibly, probably or related), and outcome of the event. AE data will be made available to the Chief Investigator (or designee) and the safety reviewers. Serious Adverse Event (SAE): an SAE is any adverse intervention experience occurring at any dose that results in any of the following outcomes: 1.1. Death 1.2. A life-threatening event (at risk of death at the time of the event) 1.3. Requires inpatient hospitalization or prolongation of existing hospitalization 1.4. A persistent or significant disability/incapacity, or 1.5. A congenital anomaly/birth defect in the offspring of a subject. Important medical events that may not result in death, be life-threatening, or require hospitalisation may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. A distinction should be drawn between serious and severe AEs. A severe AE is a major event of its type. A severe AE does not necessarily need to be considered serious. For example, nausea which persists for several hours may be considered severe nausea but would not be an SAE. On the other hand, a stroke that results in a limited degree of disability may be considered a mild stroke, but would be an SAE as meets the definition of serious (above). 2. Gastric transit time of Sirona, determined by MRI reflecting the retention of hydrogels within the stomach of participants, measured at timepoints depending on the work package (WP). WP0 MRI on da | — |
Secondary
| Measure | Time frame |
|---|---|
| WP2: 1. Glucose and HbA1c levels measured using venous blood samples at 3 and 6 months 2. Waist circumference measured using tape measure at baseline, 3 and 6 months 3. Quality of life and overall experience of repeated dosing with Sirona measured using a quality of life score (EUROQOL 5D-3L questionnaire) and Three Factor Eating Questionnaire (TFEQ) at baseline, 3 and 6 months and a qualitative interview at 6 months 4. Metabolomics measured using venous blood samples and stool samples at baseline, 3 and 6 months 5. Micronutrients measured using stool sampling at baseline, 3 and 6 months 6. Appetite measured using ecological momentary assessments weekly throughout the study 7. Dietary intake obtained from intake24 measurements at baseline, 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed