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Comparison of Taste and Palatability in Fiber Supplements

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ClinicalTrials.gov Identifier: NCT02867917
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
PF Vollebregt, VU University Medical Center

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

Condition or disease Intervention/treatment Phase
Constipation Drug: Volcolon sugar free Drug: Metamucil Orange Drug: Psyllium Orange Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Comparison of Taste and Texture of Metamucil, Volcolon and Psyllium Orange Generic
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Total group
Volcolon sugar free & Metamucil Orange & Psyllium Orange in a randomized order.
Drug: Volcolon sugar free
1 sachet contains 4 g powder 980mg/g psyllium fibers x 4 g per sachet = 3.92 g psyllium fibers/sachet

Drug: Metamucil Orange
1 sachet contains 3.4 g psyllium fibers So 25 ml contains 0.425 g psyllium fibers

Drug: Psyllium Orange
1 sachet contains 3.25 g psyllium fibers So 25 ml contains 0.406 g psyllium fibers




Primary Outcome Measures :
  1. Taste: 5-point likert scale [ Time Frame: Directly after consuming the fiber (1 minute) ]
    1. = very poor taste / unpleasant
    2. = poor taste / unpleasant
    3. = neutral
    4. = tasty / pleasant
    5. = very tasty/ very pleasant

  2. Texture: 5-point likert scale [ Time Frame: Directly after consuming the fiber (1 minute) ]
    1. = very poor taste / unpleasant
    2. = poor taste / unpleasant
    3. = neutral
    4. = tasty / pleasant
    5. = very tasty/ very pleasant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867917


Sponsors and Collaborators
VU University Medical Center
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: Richelle JF Felt-Bersma, MD, PhD VU Medical Center Amsterdam

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Responsible Party: PF Vollebregt, MD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02867917     History of Changes
Other Study ID Numbers: 2016.360
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by PF Vollebregt, VU University Medical Center:
Fibers
Constipation

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals