G-PUR® for Reduced Dietary Fumonisin Bioavailability

Reduction of Dietary Fumonisin Bioavailability Clinical Trial

Official title:

A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04494178
• Other study ID #: G-Fum_01
• Status: Terminated
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: Glock Health, Science and Research GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Reduction of Dietary Fumonisin Bioavailability

Intervention

Device:
• 2.0g G-PUR®
Oral administration (Intervention period I)
• 2.0g G-PUR®
Oral administration (Intervention period II)

Other:
• Placebo
Intervention period I
• Placebo
Intervention period II

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Glock Health, Science and Research GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2		24 hours
Secondary	Incidence of (serious) adverse device effects		19 days
Secondary	Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)		24 hours