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Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chicory inulin-type fructan
Sponsored by
Sensus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring adults, functional constipation, inulin-type fructans

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to give written informed consent
  • Between 18 and 75 years of age
  • Have functional constipation according to the Rome III Diagnostic Criteria
  • Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study
  • The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study
  • Subject is in general good health as determined by the investigator.

Exclusion Criteria:

  • Subjects less than 18 and greater than 75 years of age
  • Females who are pregnant, lactating or wish to become pregnant during the study.
  • Subjects who are hypersensitive to any of the components of the test product,
  • Subjects who have an obstructive or metabolic aetiology for constipation,
  • Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
  • Subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit,
  • Subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Chicory inulin-type fructan - placebo

    Placebo - chicory inulin-type fructan

    Arm Description

    Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin

    Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan

    Outcomes

    Primary Outcome Measures

    Change in stool frequency
    Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects.

    Secondary Outcome Measures

    Change in stool consistency
    Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.
    Patient Assessment of Constipation Symptoms
    Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire.
    Quality of life using the PAC-QOL questionnaire
    Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire
    Physical activity
    Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)
    Resort to laxatives
    Determine the resort to laxatives of the subjects
    Gut microbiota composition
    Determine the effect of chicory inulin-type fructans on gut microbiota composition

    Full Information

    First Posted
    June 28, 2022
    Last Updated
    July 1, 2022
    Sponsor
    Sensus
    Collaborators
    Atlantia Food Clinical Trials, Wageningen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05447481
    Brief Title
    Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults
    Official Title
    A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 11, 2015 (Actual)
    Primary Completion Date
    July 28, 2016 (Actual)
    Study Completion Date
    July 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sensus
    Collaborators
    Atlantia Food Clinical Trials, Wageningen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation - Functional
    Keywords
    adults, functional constipation, inulin-type fructans

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type fructans in adults with functional constipation.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Subjects were blinded to the study treatment that they received
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Chicory inulin-type fructan - placebo
    Arm Type
    Experimental
    Arm Description
    Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin
    Arm Title
    Placebo - chicory inulin-type fructan
    Arm Type
    Experimental
    Arm Description
    Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    chicory inulin-type fructan
    Intervention Description
    Dietary supplement: chicory inulin-type fructan
    Primary Outcome Measure Information:
    Title
    Change in stool frequency
    Description
    Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects.
    Time Frame
    During the 12 week intervention period
    Secondary Outcome Measure Information:
    Title
    Change in stool consistency
    Description
    Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.
    Time Frame
    During the 12 week intervention period
    Title
    Patient Assessment of Constipation Symptoms
    Description
    Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire.
    Time Frame
    During the 12 week intervention period
    Title
    Quality of life using the PAC-QOL questionnaire
    Description
    Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire
    Time Frame
    During the 12 week intervention period
    Title
    Physical activity
    Description
    Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)
    Time Frame
    During the 12 week intervention period
    Title
    Resort to laxatives
    Description
    Determine the resort to laxatives of the subjects
    Time Frame
    During the 12 week intervention period
    Title
    Gut microbiota composition
    Description
    Determine the effect of chicory inulin-type fructans on gut microbiota composition
    Time Frame
    During the 12 week intervention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to give written informed consent Between 18 and 75 years of age Have functional constipation according to the Rome III Diagnostic Criteria Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study Subject is in general good health as determined by the investigator. Exclusion Criteria: Subjects less than 18 and greater than 75 years of age Females who are pregnant, lactating or wish to become pregnant during the study. Subjects who are hypersensitive to any of the components of the test product, Subjects who have an obstructive or metabolic aetiology for constipation, Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative), Subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit, Subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elaine E Vaughan, PhD
    Organizational Affiliation
    Sensus BV
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults

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