G-PUR® for Reduced Dietary Fumonisin Bioavailability

Glock Health, Science and Research

Status: Terminated

Conditions: Reduction of Dietary Fumonisin Bioavailability

Treatments: Other: Placebo; Device: 2.0g G-PUR®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04494178

G-Fum_01

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups

2.0g G-PUR® oral - Placebo

Experimental group

Treatment:

Device: 2.0g G-PUR®

Other: Placebo

Other: Placebo

Device: 2.0g G-PUR®

Placebo - 2.0g G-PUR® oral

Experimental group

Treatment:

Device: 2.0g G-PUR®

Other: Placebo

Other: Placebo

Device: 2.0g G-PUR®