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| Name | Class |
|---|---|
| Maag Lever Darm Stichting | OTHER |
| TNO | OTHER |
| Sensus | INDUSTRY |
| Kellogg Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention phase | Experimental | From week 5-8, participants will receive the intervention, namely personalized dietary advice. |
|
| Observational phase | No Intervention | From week 1-4, participants will not receive any intervention, but just will be observed, to form as their own control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized dietary advice | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Measured during week 1, week 4 and week 8 |
| Change in constipation related quality of life after 8 weeks | Will be measured using a validated questionnaire (PAC-QoL), which has 28-items | Measured during week 1, week 4 and week 8 |
| 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) | 8 weeks |
| 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 | 8 weeks |
| Bloating | 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 | 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 | Measured daily using a mobile phone application EMA, on a 100-point visual analog scale rangeing from not at all to very severe |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | during week 1, week 4 and week 8 of the study |
| Short fiber screening questionnaire |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole de Wit, PhD | Wageningen Food and Biobased Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen University & Research | Wageningen | 6700AA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34378249 | Derived | 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. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bolletje | UNKNOWN |
| Sonneveld | UNKNOWN |
| Roquette Freres | INDUSTRY |
| Nederlands Bakkerij Centrum | OTHER |
| Wageningen Food and Biobased Research | UNKNOWN |
One group is followed over time (within person design)
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participants are not informed about the content and focus of the personalized dietary advice
|
| 8 weeks |
| 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 | 8 weeks |
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
| At screening |
| Laxative use | Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative | Daily during 8 weeks |
| Physical activity level | 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 | 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 | 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 | Will be measured from fecal samples taken by participants' at home | During week 1, week 4 and week 8 |
| Validated subjective health questionnaire | During week 1, week 4 and week 8 |
| Self-regulation questionnaire | During week 1, week 4 and week 8 |
| intention to eat fibers questionnaire | During week 1, week 4 and week 8 |
| subjective knowledge of fibers questionnaire | During week 1, week 4 and week 8 |
| outcome beliefs of fibers questionnaire | During week 1, week 4 and week 8 |
| 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 | Daily during the intervention period of 4 weeks |
| Evaluation questionnaire | That evaluates the personalized dietary advice | During week 8 |