NCT02867917

Brief Summary

The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil orange®, Volcolon® and generic orange psyllium.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1 month

First QC Date

August 10, 2016

Last Update Submit

November 1, 2017

Conditions

Constipation

Keywords

FibersConstipation

Outcome Measures

Primary Outcomes (2)

  • Taste: 5-point likert scale

    1. = very poor taste / unpleasant 2. = poor taste / unpleasant 3. = neutral 4. = tasty / pleasant 5. = very tasty/ very pleasant

    Directly after consuming the fiber (1 minute)

  • Texture: 5-point likert scale

    1. = very poor taste / unpleasant 2. = poor taste / unpleasant 3. = neutral 4. = tasty / pleasant 5. = very tasty/ very pleasant

    Directly after consuming the fiber (1 minute)

Study Arms (1)

Total group

OTHER

Volcolon sugar free \& Metamucil Orange \& Psyllium Orange in a randomized order.

Drug: Volcolon sugar freeDrug: Metamucil OrangeDrug: Psyllium Orange

Interventions

Volcolon sugar freeDRUG

1 sachet contains 4 g powder 980mg/g psyllium fibers x 4 g per sachet = 3.92 g psyllium fibers/sachet

Total group
Metamucil OrangeDRUG

1 sachet contains 3.4 g psyllium fibers So 25 ml contains 0.425 g psyllium fibers

Total group
Psyllium OrangeDRUG

1 sachet contains 3.25 g psyllium fibers So 25 ml contains 0.406 g psyllium fibers

Total group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer
  • In good health
  • Able to understand the instruction and give informed consent

You may not qualify if:

  • Gastrointestinal problems
  • Swallowing disorders
  • Rheumatic related diseases
  • Known hypersensitivity to the study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richelle JF Felt-Bersma, MD, PhD

    VU Medical Center Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 16, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share