Oral intake of mesoporous silica is safe and well tolerated in male humans

• Published in: PloS one Vol. 15; no. 10; p. e0240030
• Main Authors: Hagman, Emilia, Elimam, Amira, Kupferschmidt, Natalia, Ekbom, Kerstin, Rössner, Stephan, Iqbal, Muhammad Naeem, Johnston, Eric, Lindgren, Maria, Bengtsson, Tore, Danielsson, Pernilla
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 02.10.2020; Public Library of Science (PLoS)
• Subjects: Administration, Oral; Adult; Biology and Life Sciences; Biomarkers; Biomarkers - metabolism; Body weight loss; Cellulose; Diabetes; Dosage; Dose-response relationship; Dose-Response Relationship, Drug; FDA approval; Food; Food additives; Gastric Emptying - drug effects; Gastrointestinal surgery; Habits; Health aspects; Humans; Intestine; Lifestyles; Male; Males; Medicine and Health Sciences; Morphology; Obesity; Pore size; Porosity; Porous materials; Research and Analysis Methods; Safety; Scanning electron microscopy; Side effects; Silica; Silicon dioxide; Silicon Dioxide - administration & dosage; Silicon Dioxide - adverse effects; Silicon Dioxide - urine; Weight control; Weight loss; Young Adult; Sweden; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0240030

Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated. The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans. This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were 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). All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred. Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.