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Safety Evaluation of Porous Silica in Men

NCT03667430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-09-12

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

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

Sponsors & Collaborators

  • Sigrid Therapeutics AB, Sweden

    collaborator INDUSTRY

  • Stockholm University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Pernilla Danielsson, PhD · Karolinska Institutet

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-02-01
Completion
2016-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667430 on ClinicalTrials.gov