Safety IssuesNCT03667430
Safety Evaluation of Porous Silica in Men
A study testing Porous silica in people with Safety Issues, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Porous silica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Group - Normal weight subjects
- Age 18-35
- BMI 20-25
- Group - Subject with obesity
- Age 18-35
- BMI 30-45
Who cannot join
- 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)
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Porous silica, Placebo (microcrystalline cellulose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Porous silica; Dietary Supplement: Placebo (microcrystalline cellulose) |
| 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 Receives: Dietary Supplement: Porous silica; Dietary Supplement: Placebo (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
According to MedDRA SOC.
Measured: From start of intervention up to 12 weeks
Secondary outcomes (13)
Number of participants with affected gastrointestinal function
Evaluates by 5 graded questions of gastrointestinal habits and discomfort
Measured: From start of intervention up to 12 weeks
Presence of fecal abnormalities
Tests of Hemoglobin, calprotectin and elastase in feces
Measured: From start of intervention up to 12 weeks
Change in nutrition status
Vitamin and trace elements levels measured in blood
Measured: 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
Measured: From start of intervention up to 12 weeks
Change in glucose metabolism
Fasting glucose, insulin and hemoglobin A1c in blood
Measured: From start of intervention up to 12 weeks
Change in liver status
Alanine aminotransferase and aspartate aminotransferase in blood
Measured: From start of intervention up to 12 weeks
Change in renal status measured by creatinine
Creatinine in blood
Measured: From start of intervention up to 12 weeks
Change in renal status measured by glomerular filtration rate
Glomerular filtration rate in blood
Measured: From start of intervention up to 12 weeks
Change in renal status measured by cystatin C
Cystatin C in blood
Measured: From start of intervention up to 12 weeks
Change in concentration of silica
Urine sample
Measured: From start of intervention up to 12 weeks
Change in systemic inflammation status
C-reactive protein in blood
Measured: From start of intervention up to 12 weeks
Change in blood pressure
Diastolic and systolic blood pressure
Measured: From start of intervention up to 12 weeks
Body weight
Weight (kg)
Measured: From start of intervention up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Sep 2015
- Primary completion1 Feb 2016
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Sigrid Therapeutics AB, Sweden, Stockholm University
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667430
- Sponsor's protocol ID
- Sigrid1
- Status last verified
- Sep 2018
- First submitted
- 23 Aug 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03667430
- Acronym / sponsor ID
- Sigrid1
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Sigrid Therapeutics AB, Sweden, Stockholm University
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight subjects | Experimental | Dietary Supplement: Porous silica, Dietary Supplement: Placebo (microcrystalline cellulose)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 | Dietary Supplement: Porous silica, Dietary Supplement: Placebo (microcrystalline cellulose)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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Group - Normal weight subjects
- Age 18-35
- BMI 20-25
- Group - Subject with obesity
- Age 18-35
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porous silicaThe 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. | Dietary supplement | Normal weight subjects, Subjects with obesity |
| Placebo (microcrystalline cellulose)All participants starts with five days placebo run in period | Dietary supplement | Normal weight subjects, Subjects with obesity |
Primary outcome
Adverse events
Time frame: From start of intervention up to 12 weeks
According to MedDRA SOC.
13 secondary outcomes
Number of participants with affected gastrointestinal function
Time frame: From start of intervention up to 12 weeks
Presence of fecal abnormalities
Time frame: From start of intervention up to 12 weeks
Change in nutrition status
Time frame: From start of intervention up to 12 weeks
Change in lipid profile
Time frame: From start of intervention up to 12 weeks
Change in glucose metabolism
Time frame: From start of intervention up to 12 weeks
Change in liver status
Time frame: From start of intervention up to 12 weeks
Change in renal status measured by creatinine
Time frame: From start of intervention up to 12 weeks
Change in renal status measured by glomerular filtration rate
Time frame: From start of intervention up to 12 weeks
Change in renal status measured by cystatin C
Time frame: From start of intervention up to 12 weeks
Change in concentration of silica
Time frame: From start of intervention up to 12 weeks
Change in systemic inflammation status
Time frame: From start of intervention up to 12 weeks
Change in blood pressure
Time frame: From start of intervention up to 12 weeks
Body weight
Time frame: From start of intervention up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Danielsson, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Porous silica in people with Safety Issues, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From start of intervention up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.