Clinical trial NCT03667430: Safety Evaluation of Porous Silica in Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Sigrid Therapeutics AB, Sweden
name: Stockholm University
First posted: 2018-09-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: From start of intervention up to 12 weeks
Secondary outcomes:
measure: Number of participants with affected gastrointestinal function
timeFrame: From start of intervention up to 12 weeks
measure: Presence of fecal abnormalities
timeFrame: From start of intervention up to 12 weeks
measure: Change in nutrition status
timeFrame: From start of intervention up to 12 weeks
measure: Change in lipid profile
timeFrame: From start of intervention up to 12 weeks
measure: Change in glucose metabolism
timeFrame: From start of intervention up to 12 weeks
measure: Change in liver status
timeFrame: From start of intervention up to 12 weeks
measure: Change in renal status measured by creatinine
timeFrame: From start of intervention up to 12 weeks
measure: Change in renal status measured by glomerular filtration rate
timeFrame: From start of intervention up to 12 weeks
measure: Change in renal status measured by cystatin C
timeFrame: From start of intervention up to 12 weeks
measure: Change in concentration of silica
timeFrame: From start of intervention up to 12 weeks
measure: Change in systemic inflammation status
timeFrame: From start of intervention up to 12 weeks
measure: Change in blood pressure
timeFrame: From start of intervention up to 12 weeks
measure: Body weight
timeFrame: From start of intervention up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: