Safety Issues Clinical Trial
Official title:
Tolerability and Feasibility Evaluation of a Food Additive Based on Porous Silica Compounds for Future Weight Loss and Prevention of Obesity Related Co-morbidities
The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on gastrointestinal function, bowel emptying habits, and biomarkers.
This single blinded safety study will consist of two study arms and include 10 males each
(18-35 years). One arm will include participants with normal weight and one with obesity.
After a placebo run-in period, all subjects will be given porous silica three times daily,
with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study
with highest dose for additional 10 weeks (Phase 2).
The participants will have weekly contacts during with the representative for the study (PI
or other research staff). Clinical examinations, and blood sampling will be performed day 1,
7, 14, and 21. Faeces and morning urinary sampling day 1, and 21. Information regarding
eating habits, sleep patterns, living conditions and gastrointestinal health were obtained
from written forms and orally. If gastrointestinal adverse events would occur after increased
dosage, the study staff will adapt the dosage protocol to facilitate adherence.
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