Safety Evaluation of Porous Silica in Men

Safety Issues Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667430
• Other study ID #: Sigrid1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: February 1, 2016

Study information

• Verified date: September 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

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.
• Placebo (microcrystalline cellulose)
All participants starts with five days placebo run in period

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Sigrid Therapeutics AB, Sweden, Stockholm University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	According to MedDRA SOC.	From start of intervention up to 12 weeks
Secondary	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
Secondary	Presence of fecal abnormalities	Tests of Hemoglobin, calprotectin and elastase in feces	From start of intervention up to 12 weeks
Secondary	Change in nutrition status	Vitamin and trace elements levels measured in blood	From start of intervention up to 12 weeks
Secondary	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
Secondary	Change in glucose metabolism	Fasting glucose, insulin and hemoglobin A1c in blood	From start of intervention up to 12 weeks
Secondary	Change in liver status	Alanine aminotransferase and aspartate aminotransferase in blood	From start of intervention up to 12 weeks
Secondary	Change in renal status measured by creatinine	Creatinine in blood	From start of intervention up to 12 weeks
Secondary	Change in renal status measured by glomerular filtration rate	Glomerular filtration rate in blood	From start of intervention up to 12 weeks
Secondary	Change in renal status measured by cystatin C	Cystatin C in blood	From start of intervention up to 12 weeks
Secondary	Change in concentration of silica	Urine sample	From start of intervention up to 12 weeks
Secondary	Change in systemic inflammation status	C-reactive protein in blood	From start of intervention up to 12 weeks
Secondary	Change in blood pressure	Diastolic and systolic blood pressure	From start of intervention up to 12 weeks
Secondary	Body weight	Weight (kg)	From start of intervention up to 12 weeks