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Completed

NCT Number: NCT05447481

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

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.

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Key information

Conditions

Constipation - Functional

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chicory inulin-type fructan

Dietary Supplement

Dietary supplement: chicory inulin-type fructan

Primary outcomes

  1. Change in stool frequency

    Time frame: During the 12 week intervention period

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

Secondary outcomes

  1. Change in stool consistency

    Time frame: During the 12 week intervention period

    Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.

  2. Patient Assessment of Constipation Symptoms

    Time frame: During the 12 week intervention period

    Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire.

  3. Quality of life using the PAC-QOL questionnaire

    Time frame: During the 12 week intervention period

    Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire

  4. Physical activity

    Time frame: During the 12 week intervention period

    Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)

  5. Resort to laxatives

    Time frame: During the 12 week intervention period

    Determine the resort to laxatives of the subjects

  6. Gut microbiota composition

    Time frame: During the 12 week intervention period

    Determine the effect of chicory inulin-type fructans on gut microbiota composition

Sponsors and collaborators

Lead sponsor

Sensus

Industry

Collaborators

  • Atlantia Food Clinical Trials
  • Wageningen University

Registry information

Official study title

A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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