Safety Evaluation of Porous Silica in Men

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Dietary supplement: Porous silica; Dietary supplement: Placebo (microcrystalline cellulose)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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.; Dietary supplement: Placebo (microcrystalline cellulose); All participants starts with five days placebo run in period
Experimental: 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	Dietary supplement: 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.; Dietary supplement: Placebo (microcrystalline cellulose); All participants starts with five days placebo run in period

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm University; Sigrid Therapeutics AB, Sweden
• Investigators: Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Sigrid1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No