Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice (PAC)

January 19, 2021 updated by: Wageningen University

Rationale: constipation-related complaints are prevalent in 5-20% of the population.

Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool weight, stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary advice may be the solution to increase dietary fiber intake and reduce constipation-related complaints in large populations. Objective: To investigate the effectiveness of personalized dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber intake in people with constipation-related complaints. Study design: This study has a one-group pre-test post-test design with a run-in period.

The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week intervention period. All subjects receive the PDA. Study population: adult subjects with constipation-related complaints, defined as predominant Bristol stool form between 1-4 and not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool frequency ≤4 stools per week will be included as a definition. Subjects need to have a relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males), which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a special algorithm, the PDA provides high fiber alternatives for low-fiber products that subjects currently use, close to their current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal.

Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal complaints and constipation quality of life and severity. Secondary parameters include dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6700AA
        • Wageningen University & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18- 55 years
  • BMI <30 kg/m2

  • Has constipation related complaints: response <6 to the question "how satisfied are you with your stool pattern", which is rated on a visual analog scale (VAS) from 1-10, together with at least one of the following criteria:

    1. Habitual stool form of Bristol stool type 1-4 or
    2. ≤4 defecations per week
  • living in the surroundings of wageningen (max. 50km)
  • in possession of a computer with chrome browser and a mobile phone compatible with applications Note: these criteria are less stringent than the official "constipation" definition, because we preferably want to include participants that do not use laxatives (yet), and we assume that in this 'mild constipation' group increasing fiber intake can have the most beneficial effects. Moreover, we chose not to use the Rome IV criteria as definition of constipation-related complaints, due to the proven inability to distinguish functional constipation from Irritable Bowel Syndrome. If there are sufficient eligible participants, the participants with the lowest stool frequency will be selected
  • Relatively low fiber intake (females <26 grams, males <33 grams). When enough eligible participants are available, we will choose the participants with the lowest dietary fiber intake.
  • signed informed consent

Exclusion Criteria:

  • Subjects with a disease that may interfere with the personal dietary advice or outcomes, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
  • Currently following strict diet and unwilling or unable to change; for example a gluten free diet or a "crash diet" using meal substitutes
  • Use of medication that can interfere with the study outcomes, including diuretics, antidepressants, codeine, antibiotics or fiber supplements. Preferably laxative use is excluded, but if recruitment is hurdled by this, we at least exclude specific laxatives like resolor, relistor and constella. These are laxatives who have a significant impact on bowel movements, and are only available on prescription. Osmotic (over the counter available) laxatives will be included if recruitment is difficult. Subjects will then be asked to keep their laxative use stable or reduce, but not to increase usage from their habitual pattern (unless necessary, but then report it to the researchers). Moreover, additional questions regarding laxative usage will be included to estimate the effect of laxatives on stool pattern.
  • Female subjects: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing.
  • Are simultaneously participating in another study.
  • Unwilling or unable to fulfil the study criteria.
  • Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition & Health, Wageningen University.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention phase
From week 5-8, participants will receive the intervention, namely personalized dietary advice.
Behavioral: Personalized dietary advice
Via an self-developed website and algorithm, participants will receive digital personalized dietary advice to increase dietary fiber intake, aiming to reduce constipation complaints. The advice is personalized on phenotype (habitual diet, gender)
No Intervention: Observational phase
From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in constipation severity after 8 weeks
Time Frame: Measured during week 1, week 4 and week 8
Will be measured using a validated questionnaire PAC-SYM, which has 12 items. Scores can range between 1 (not severe) and 4 points (vere severe)
Measured during week 1, week 4 and week 8
Change in constipation related quality of life after 8 weeks
Time Frame: Measured during week 1, week 4 and week 8
Will be measured using a validated questionnaire (PAC-QoL), which has 28-items
Measured during week 1, week 4 and week 8
Stool pattern
Time Frame: 8 weeks
Will be assessed daily using a mobile phone application (using ecogological momentary assessment, EMA). Subjects will indicate each day whether they had defecation and which type of defecation it was (based on the bristol stool chart)
8 weeks
Abdominal pain
Time Frame: 8 weeks
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
8 weeks
Bloating
Time Frame: 8 weeks
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
8 weeks
Flatulence
Time Frame: 8 weeks
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
8 weeks
Fatigue
Time Frame: 8 weeks
Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe
8 weeks
Abdominal cramps
Time Frame: 8 weeks
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary fiber intake
Time Frame: during week 1, week 4 and week 8 of the study
Measured by 24hr recall. Each measurement will consist of 3 days to take variance into account (1 weekend day and 2 weekdays)
during week 1, week 4 and week 8 of the study
Short fiber screening questionnaire
Time Frame: At screening
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
At screening
Laxative use
Time Frame: Daily during 8 weeks
Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
Daily during 8 weeks
Physical activity level
Time Frame: during week 1, week 4 and week 8
Will be measured by the validated short questionnaire to assess health-enhancing physical activity (SQUASH)
during week 1, week 4 and week 8
Body weight
Time Frame: During week 1, week 4 and week 8
Measured during study visits on a weighing scale
During week 1, week 4 and week 8
Microbiota composition from fecal samples, as assessed by 16S rRNA sequencing
Time Frame: During week 1, week 4, and week 8
Will be measured from fecal samples taken by participants' at home
During week 1, week 4, and week 8
short-chain fatty acid levels from fecal samples, assessed by HPLC
Time Frame: During week 1, week 4 and week 8
Will be measured from fecal samples taken by participants' at home
During week 1, week 4 and week 8
Validated subjective health questionnaire
Time Frame: During week 1, week 4 and week 8
During week 1, week 4 and week 8
Self-regulation questionnaire
Time Frame: During week 1, week 4 and week 8
During week 1, week 4 and week 8
intention to eat fibers questionnaire
Time Frame: During week 1, week 4 and week 8
During week 1, week 4 and week 8
subjective knowledge of fibers questionnaire
Time Frame: During week 1, week 4 and week 8
During week 1, week 4 and week 8
outcome beliefs of fibers questionnaire
Time Frame: During week 1, week 4 and week 8
During week 1, week 4 and week 8
self-efficacy of fiber intake
Time Frame: Daily during the intervention period of 4 weeks
Measured by the question: did you manage to eat more fiber today: on a 100-point visual analog scale from "not at all" to "yes, completely" using a mobile phone application on the phone
Daily during the intervention period of 4 weeks
Evaluation questionnaire
Time Frame: During week 8
That evaluates the personalized dietary advice
During week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roquette Frères
TNO
Kellogg Company
Maag Lever Darm Stichting
Sensus
Bolletje
Sonneveld
Nederlands Bakkerij Centrum
Wageningen Food and Biobased Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole de Wit, PhD, Wageningen Food and Biobased Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL73256.028.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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