Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-09-01
2016-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Normal weight subjects
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
Porous silica
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)
All participants starts with five days placebo run in period
Subjects with obesity
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
Porous silica
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)
All participants starts with five days placebo run in period
Interventions
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Porous silica
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)
All participants starts with five days placebo run in period
Eligibility Criteria
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Inclusion Criteria
* Age 18-35
* BMI 20-25
Group - Subject with obesity
* Age 18-35
* BMI 30-45
Exclusion Criteria
* 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
18 Years
35 Years
MALE
Yes
Sponsors
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Sigrid Therapeutics AB, Sweden
INDUSTRY
Stockholm University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Pernilla Danielsson
Principal Investigator
Principal Investigators
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Pernilla Danielsson, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Other Identifiers
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Sigrid1
Identifier Type: -
Identifier Source: org_study_id
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