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

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Personalized dietary advice
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Dietary fiber, Personalized advice

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wageningen University & Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention phase

Observational phase

Arm Description

From week 5-8, participants will receive the intervention, namely personalized dietary advice.

From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control

Outcomes

Primary Outcome Measures

Change in constipation severity after 8 weeks
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)
Change in constipation related quality of life after 8 weeks
Will be measured using a validated questionnaire (PAC-QoL), which has 28-items
Stool pattern
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)
Abdominal pain
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Bloating
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Flatulence
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Fatigue
Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe
Abdominal cramps
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe

Secondary Outcome Measures

Dietary fiber intake
Measured by 24hr recall. Each measurement will consist of 3 days to take variance into account (1 weekend day and 2 weekdays)
Short fiber screening questionnaire
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
Laxative use
Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
Physical activity level
Will be measured by the validated short questionnaire to assess health-enhancing physical activity (SQUASH)
Body weight
Measured during study visits on a weighing scale
Microbiota composition from fecal samples, as assessed by 16S rRNA sequencing
Will be measured from fecal samples taken by participants' at home
short-chain fatty acid levels from fecal samples, assessed by HPLC
Will be measured from fecal samples taken by participants' at home
Validated subjective health questionnaire
Self-regulation questionnaire
intention to eat fibers questionnaire
subjective knowledge of fibers questionnaire
outcome beliefs of fibers questionnaire
self-efficacy of fiber intake
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
Evaluation questionnaire
That evaluates the personalized dietary advice

Full Information

First Posted
June 18, 2020
Last Updated
January 19, 2021
Sponsor
Wageningen University
Collaborators
Maag Lever Darm Stichting, TNO, Sensus, Kellogg Company, Bolletje, Sonneveld, Roquette Freres, Nederlands Bakkerij Centrum, Wageningen Food and Biobased Research
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1. Study Identification

Unique Protocol Identification Number
NCT04457791
Brief Title
Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice
Acronym
PAC
Official Title
Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
Maag Lever Darm Stichting, TNO, Sensus, Kellogg Company, Bolletje, Sonneveld, Roquette Freres, Nederlands Bakkerij Centrum, Wageningen Food and Biobased Research

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Dietary fiber, Personalized advice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group is followed over time (within person design)
Masking
Participant
Masking Description
participants are not informed about the content and focus of the personalized dietary advice
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention phase
Arm Type
Experimental
Arm Description
From week 5-8, participants will receive the intervention, namely personalized dietary advice.
Arm Title
Observational phase
Arm Type
No Intervention
Arm Description
From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control
Intervention Type
Behavioral
Intervention Name(s)
Personalized dietary advice
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in constipation severity after 8 weeks
Description
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)
Time Frame
Measured during week 1, week 4 and week 8
Title
Change in constipation related quality of life after 8 weeks
Description
Will be measured using a validated questionnaire (PAC-QoL), which has 28-items
Time Frame
Measured during week 1, week 4 and week 8
Title
Stool pattern
Description
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)
Time Frame
8 weeks
Title
Abdominal pain
Description
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Time Frame
8 weeks
Title
Bloating
Description
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Time Frame
8 weeks
Title
Flatulence
Description
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Time Frame
8 weeks
Title
Fatigue
Description
Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe
Time Frame
8 weeks
Title
Abdominal cramps
Description
Measured daily using a mobile phone application EMA, on a 10-point visual analog scale rangeing from not at all to very severe
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dietary fiber intake
Description
Measured by 24hr recall. Each measurement will consist of 3 days to take variance into account (1 weekend day and 2 weekdays)
Time Frame
during week 1, week 4 and week 8 of the study
Title
Short fiber screening questionnaire
Description
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
Time Frame
At screening
Title
Laxative use
Description
Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
Time Frame
Daily during 8 weeks
Title
Physical activity level
Description
Will be measured by the validated short questionnaire to assess health-enhancing physical activity (SQUASH)
Time Frame
during week 1, week 4 and week 8
Title
Body weight
Description
Measured during study visits on a weighing scale
Time Frame
During week 1, week 4 and week 8
Title
Microbiota composition from fecal samples, as assessed by 16S rRNA sequencing
Description
Will be measured from fecal samples taken by participants' at home
Time Frame
During week 1, week 4, and week 8
Title
short-chain fatty acid levels from fecal samples, assessed by HPLC
Description
Will be measured from fecal samples taken by participants' at home
Time Frame
During week 1, week 4 and week 8
Title
Validated subjective health questionnaire
Time Frame
During week 1, week 4 and week 8
Title
Self-regulation questionnaire
Time Frame
During week 1, week 4 and week 8
Title
intention to eat fibers questionnaire
Time Frame
During week 1, week 4 and week 8
Title
subjective knowledge of fibers questionnaire
Time Frame
During week 1, week 4 and week 8
Title
outcome beliefs of fibers questionnaire
Time Frame
During week 1, week 4 and week 8
Title
self-efficacy of fiber intake
Description
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
Time Frame
Daily during the intervention period of 4 weeks
Title
Evaluation questionnaire
Description
That evaluates the personalized dietary advice
Time Frame
During week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Habitual stool form of Bristol stool type 1-4 or ≤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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole de Wit, PhD
Organizational Affiliation
Wageningen Food and Biobased Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University & Research
City
Wageningen
ZIP/Postal Code
6700AA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34378249
Citation
Rijnaarts I, de Roos N, Zoetendal EG, de Wit N, Witteman BJM. Development and validation of the FiberScreen: A short questionnaire to screen fibre intake in adults. J Hum Nutr Diet. 2021 Dec;34(6):969-980. doi: 10.1111/jhn.12941. Epub 2021 Aug 29.
Results Reference
derived

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Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice

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