Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice

NCT04457791 | Completed

• 1 other identifier: NL73256.028.20
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Dietary fiber; Personalized advice

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (14)

• Dietary fiber intake

  during week 1, week 4 and week 8 of the study

• Short fiber screening questionnaire

  At screening

• Laxative use

  Daily during 8 weeks

• Physical activity level

  during week 1, week 4 and week 8

• Body weight

  During week 1, week 4 and week 8

Study Arms (2)

Intervention phase

EXPERIMENTAL

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

Behavioral: 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

Interventions

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)

Intervention phase

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead
• Maag Lever Darm Stichting: collaborator
• TNO: collaborator
• Sensus: collaborator
• Kellogg Company: collaborator
• Bolletje: collaborator
• Sonneveld: collaborator
• Roquette Freres: collaborator
• Nederlands Bakkerij Centrum: collaborator
• Wageningen Food and Biobased Research: collaborator

Study Sites (1)

Wageningen University & Research

Wageningen, 6700AA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34378249 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole de Wit, PhD

  Wageningen Food and Biobased Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are not informed about the content and focus of the personalized dietary advice
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group is followed over time (within person design)

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 7, 2020
• Study Start: August 31, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

NL (1)