Safety Evaluation of Porous Silica in Men

Not Applicable

Completed

• Conditions: Safety Issues
• Interventions: Dietary Supplement: Porous silica; Dietary Supplement: Placebo (microcrystalline cellulose)

• Registration Number: NCT03667430
• Lead Sponsor: Karolinska Institutet

Brief 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.

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 Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-02-01
• Study Completion: 2016-02-01
• Study First Submitted: 2018-08-23
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Group - Normal weight subjects

• Age 18-35
• BMI 20-25

Group - Subject with obesity

• Age 18-35
• BMI 30-45

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal weight subjects	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
Normal weight subjects	Porous silica	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	Porous silica	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
Subjects with obesity	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

Primary Outcome Measures

Name	Time	Method
Adverse events	From start of intervention up to 12 weeks	According to MedDRA SOC.

Secondary Outcome Measures

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