Wageningen University & Research
Wageningen, 6700AA, Netherlands
NCT Number: NCT04457791
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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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Wageningen, 6700AA, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
Time frame: Measured during week 1, week 4 and week 8
Will be measured using a validated questionnaire (PAC-QoL), which has 28-items
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)
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
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
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
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
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
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)
Time frame: At screening
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
Time frame: Daily during 8 weeks
Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
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)
Time frame: During week 1, week 4 and week 8
Measured during study visits on a weighing scale
Time frame: During week 1, week 4, and week 8
Will be measured from fecal samples taken by participants' at home
Time frame: During week 1, week 4 and week 8
Will be measured from fecal samples taken by participants' at home
Time frame: During week 1, week 4 and week 8
Time frame: During week 1, week 4 and week 8
Time frame: During week 1, week 4 and week 8
Time frame: During week 1, week 4 and week 8
Time frame: During week 1, week 4 and week 8
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
Time frame: During week 8
That evaluates the personalized dietary advice
Wageningen University
Other
Acronym: PAC
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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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