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| Name | Class |
|---|---|
| Sigrid Therapeutics AB, Sweden | INDUSTRY |
| Stockholm University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight subjects | Experimental | 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 |
|
| Subjects with obesity | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porous silica | Dietary 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | According to MedDRA SOC. | From start of intervention up to 12 weeks |
| 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 |
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Inclusion Criteria:
Group - Normal weight subjects
Group - Subject with obesity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernilla Danielsson, PhD | Karolinska Institutet | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2020 | |
| Reset | Dec 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2020 | Dec 15, 2020 |
| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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| Placebo (microcrystalline cellulose) | Dietary Supplement | All participants starts with five days placebo run in period |
|
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 |