NCT03667430

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

August 23, 2018

Last Update Submit

September 11, 2018

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    According to MedDRA SOC.

    From start of intervention up to 12 weeks

Secondary Outcomes (13)

  • Number of participants with affected gastrointestinal function

    From start of intervention up to 12 weeks

  • Presence of fecal abnormalities

    From start of intervention up to 12 weeks

  • Change in nutrition status

    From start of intervention up to 12 weeks

  • Change in lipid profile

    From start of intervention up to 12 weeks

  • Change in glucose metabolism

    From start of intervention up to 12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Normal weight subjects

EXPERIMENTAL

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 silicaDietary Supplement: Placebo (microcrystalline cellulose)

Subjects with obesity

EXPERIMENTAL

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 silicaDietary Supplement: Placebo (microcrystalline cellulose)

Interventions

Porous silicaDIETARY_SUPPLEMENT

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.

Normal weight subjectsSubjects with obesity
Placebo (microcrystalline cellulose)DIETARY_SUPPLEMENT

All participants starts with five days placebo run in period

Normal weight subjectsSubjects with obesity

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Group - Normal weight subjects
  • Age 18-35
  • BMI 20-25
  • Group - Subject with obesity
  • Age 18-35
  • BMI 30-45

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

microcrystalline cellulose

Study Officials

  • Pernilla Danielsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

September 12, 2018

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 12, 2018

Record last verified: 2018-09