Safety Evaluation of Porous Silica in Men

Karolinska Institutet20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Safety Issues

Interventions

Porous silicaDIETARY_SUPPLEMENT

The particle is rod shaped and approximately 1-3 x 0.4-0.5 micrometers with pore sizes in the range of 70-130 Ångström or 7-13 nanometer.

Placebo (microcrystalline cellulose)DIETARY_SUPPLEMENT

All participants starts with five days placebo run in period

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Group - Normal weight subjects * Age 18-35 * BMI 20-25 Group - Subject with obesity * Age 18-35 * BMI 30-45 Exclusion Criteria: * Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disease, gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease,) * Allergies with previous anaphylactic reactions * Previous abdominal surgery * Current or history of eating disorders * Extreme or unusual diets such as Low Carb High Fat and vegetarian diets for the last year * Psychiatric disorders (e.g. schizophrenia, and other diagnoses that may influence compliance) * Drug or alcohol abuse * Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study * Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance