Safety Evaluation of Porous Silica in Men

Karolinska Institute

Status: Completed

Conditions: Safety Issues

Treatments: Dietary Supplement: Porous silica; Dietary Supplement: Placebo (microcrystalline cellulose)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03667430

Sigrid1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Normal weight subjects

Experimental group

Description:

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

Treatment:

Dietary Supplement: Porous silica

Dietary Supplement: Placebo (microcrystalline cellulose)

Subjects with obesity

Experimental group

Description:

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

Treatment:

Dietary Supplement: Porous silica

Dietary Supplement: Placebo (microcrystalline cellulose)