Reduction of Dietary Fumonisin Bioavailability
Conditions
Brief summary
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.
Interventions
DEVICE2.0g G-PUR®
Oral administration (Intervention period I)
OTHERPlacebo
Intervention period I
Sponsors
Glock Health, Science and Research GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female subjects 2. Age 18-55 years 3. BMI 17-27 4. Subjects are in good clinical and mental health as established by medical history and physical examination 5. Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan 6. Written informed consent
Exclusion criteria
1. Pregnancy or breastfeeding. 2. Lack of willingness or capacity to co-operate appropriately 3. Regular use of medications in the previous 2 months (except oral contraception) 4. History of malignancies within the past two years or on current anticancer treatment 5. History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation 6. History of diarrhoea within the past 14 days of screening 7. History of gastrointestinal surgery with exception of appendectomy 8. History of any chronic liver disease 9. History of autoimmune disease requiring treatment within the past two months of screening 10. Known symptomatic food allergies 11. Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination 12. Hypersensitivity to aluminium and/or silicon 13. Chronic renal disease requiring dialysis 14. Alcohol, cigarette or drug abuse 15. Presence of any condition that impacts compliance with the study procedures 16. Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period 17. Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2 | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of (serious) adverse device effects | 19 days |
| Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2) | 24 hours |
Countries
Austria
Outcome results
None listed