Safety Evaluation of Porous Silica in Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tolerability and Feasibility Evaluation of a Food Additive Based on Porous Silica Compounds for Future Weight Loss and Prevention of Obesity Related Co-morbidities

Conditions
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Safety Issues

Intervention / Treatment
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* Dietary Supplement: Porous silica
* Dietary Supplement: Placebo (microcrystalline cellulose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal weight subjects<br>Healthy normal weight (BMI 20-25) men 18-35 year. Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 Total study time 21 days | Dietary Supplement: Porous silica<br>* 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.<br>Dietary Supplement: Placebo (microcrystalline cellulose)<br>* All participants starts with five days placebo run in period<br>|
| Experimental: Subjects with obesity<br>Obese otherwise healthy men (BMI 30-45) 18-35 year Intervention: The participants will take placebo or silica powder with specified doses administrated in vials and with instructions to mix with water as; Placebo (microcrystalline cellulose) day 1-5 Porous silica 1gx3 daily for day 6-9 Porous silica 2gx3 daily for day 10-14 Porous silica 3gx3 daily for day 15-21 The dose of Silica 3gx3 for additional 10 weeks Total study time 84 days | Dietary Supplement: Porous silica<br>* 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.<br>Dietary Supplement: Placebo (microcrystalline cellulose)<br>* All participants starts with five days placebo run in period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | According to MedDRA SOC. | From start of intervention up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with affected gastrointestinal function | Evaluates by 5 graded questions of gastrointestinal habits and discomfort | From start of intervention up to 12 weeks | 
| Presence of fecal abnormalities | Tests of Hemoglobin, calprotectin and elastase in feces | From start of intervention up to 12 weeks | 
| Change in nutrition status | Vitamin and trace elements levels measured in blood | From start of intervention up to 12 weeks | 
| Change in lipid profile | Triglycerides, total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol in blood | From start of intervention up to 12 weeks | 
| Change in glucose metabolism | Fasting glucose, insulin and hemoglobin A1c in blood | From start of intervention up to 12 weeks | 
| Change in liver status | Alanine aminotransferase and aspartate aminotransferase in blood | From start of intervention up to 12 weeks | 
| Change in renal status measured by creatinine | Creatinine in blood | From start of intervention up to 12 weeks | 
| Change in renal status measured by glomerular filtration rate | Glomerular filtration rate in blood | From start of intervention up to 12 weeks | 
| Change in renal status measured by cystatin C | Cystatin C in blood | From start of intervention up to 12 weeks | 
| Change in concentration of silica | Urine sample | From start of intervention up to 12 weeks | 
| Change in systemic inflammation status | C-reactive protein in blood | From start of intervention up to 12 weeks | 
| Change in blood pressure | Diastolic and systolic blood pressure | From start of intervention up to 12 weeks | 
| Body weight | Weight (kg) | From start of intervention up to 12 weeks |