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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
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)
Wageningen University & Research
Wageningen, Netherlands
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
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)
Time frame: during week 1, week 4 and week 8 of the study
Short fiber screening questionnaire
Validation of a short fiber screening questionnaire: 18-item questionnaire assessing fiber intake
Time frame: At screening
Laxative use
Measured daily using a mobile phone application EMA: did you use laxatives today. If yes: which laxative
Time frame: Daily during 8 weeks
Physical activity level
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
Body weight
Measured during study visits on a weighing scale
Time frame: 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
Time frame: 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
Time frame: During week 1, week 4 and week 8
Validated subjective health questionnaire
Time frame: During week 1, week 4 and week 8
Self-regulation questionnaire
Time frame: During week 1, week 4 and week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
intention to eat fibers questionnaire
Time frame: During week 1, week 4 and week 8
subjective knowledge of fibers questionnaire
Time frame: During week 1, week 4 and week 8
outcome beliefs of fibers questionnaire
Time frame: 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
Time frame: Daily during the intervention period of 4 weeks
Evaluation questionnaire
That evaluates the personalized dietary advice
Time frame: During week 8