G-PUR® for Reduced Dietary Fumonisin Bioavailability

Not Applicable

Terminated

• Conditions: Reduction of Dietary Fumonisin Bioavailability
• Interventions: Device: 2.0g G-PUR®; Other: Placebo

• Registration Number: NCT04494178
• Lead Sponsor: Glock Health, Science and Research GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2020-08-18
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2.0g G-PUR® oral - Placebo	Placebo	-
Placebo - 2.0g G-PUR® oral	2.0g G-PUR®	-
Placebo - 2.0g G-PUR® oral	Placebo	-
2.0g G-PUR® oral - Placebo	2.0g G-PUR®	-

Primary Outcome Measures

Name	Time	Method
The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2	24 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of (serious) adverse device effects	19 days
Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)	24 hours

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria