Clinical trial NCT03848546: Stimulating Fiber Intake Via Personalized Dietary Advice
Official title: Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Dietary Fiber
Personalized Advice
Microbiota
Keywords: fiber intake
personalized dietary advice
stool pattern
perceived wellbeing
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
name: Dutch Association for Gastrointestinal diseases (MLDS)
name: Bolletje
name: Sensus
name: Sonneveld
name: Kellogg Company
First posted: 2019-02-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: one receives general advice (control), the other personalized advice (intervention). Subjects are followed over time.
Primary purpose: PREVENTION

Brief summary: Dietary fibers are linked to improved health and prevention of diseases such as obesity, stroke, hypertension, diabetes and colorectal cancer. Moreover, fibers play a crucial role in improving and maintaining gut health, by increasing stool weight,stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams per day. Personalized dietary advice may be the solution to increase dietary fiber intake in large populations.

The objective is to investigate if a personalized dietary advice is more effective in increasing dietary fiber intake in the Dutch population than the general advice that is currently provided by the Netherlands Nutrition center and the Dutch Digestive Foundation (MLDS).Second objective is to assess the effect of increased fiber intake on stool pattern, perceived well-being and consumer behavior parameters and the role of psychological factors in the effectiveness of personalized dietary advice on dietary fiber intake.

Study design: A 4.5-month (6 weeks intervention + follow-up after 3 months) single-blind randomized controlled trial with two groups: the intervention group, which receives personalized dietary advice (PDA), and the control group, which only receives the general dietary advice. Primary study parameters/outcome of the study: Primary endpoint is dietary fiber intake, which will be assessed using an Food Frequency Questionnaire and 24hr recalls.

Fecal microbiota composition and metabolite levels will be used as an objective marker for fiber intake. Secondary study parameters/outcome of the study (if applicable):

Secondary parameters include stool pattern, well-being, hunger, satiety and body weight. Furthermore, psychological measurements will give insight into why the PDA was (not) effective.

Detailed description: This study is performed in healthy adults, older than 18 years, with no gastro-intestinal complaints. The intervention group receives personalized dietary advice (PDA) based on their current food pattern, preferences and selfregulation capacity. The PDA aims to compute high-fiber alternatives for products that subjects currently use and that are close to their current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online webportal. The control group only receives a general dietary advice, e.g. (a) flyer(s) containing information on fibers from the Netherlands Nutrition Center and the MLDS. The intervention group will also receive this general advice next to the PDA.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years.
* Apparently healthy: no gastrointestinal complaints, no food allergies and no medication that can influence the outcome of the study (see exclusion criteria).
* Relatively low fiber intake: which is assessed by a short fiber intake screening questionnaire (score ranging from

  1 to 22). Females with a score ≤13 and males with a score ≤15 will be included in the study.
* Living in the surroundings of Wageningen (max. 50 km).
* In possession of a mobile phone with android ≥4.4 or iOS system ≥9 to use apps.
* Signed informed consent.

Exclusion Criteria:

* Any digestive tract disorder that is expected to interfere with the study outcomes, such as chronic constipation or diarrhea, Crohn's Disease, Ulcerative Colitis, Irritable Bowel Syndrome, Coeliac disease.
* Diagnosis of Diabetes Mellitus, since the change in carbohydrate intake may interfere with medication usage.
* Currently following a 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 laxatives, diuretics, antidepressants, codeine, antibiotics or fiber supplements
* Female subjects: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and well-being.
* Simultaneously participating in another study.
* Unwilling or unable to fulfill the study criteria.

Primary outcomes:
measure: Change in dietary fiber intake
timeFrame: Before study, after 6 weeks intervention, and 3 months follow-up
measure: change in Short Chain Fatty acid level
timeFrame: Before study, at 3 weeks and at 6 weeks
measure: change in Microbiota composition
timeFrame: Before study, at 3 weeks and at 6 weeks
Secondary outcomes:
measure: Stool pattern
timeFrame: Daily during 6-week intervention
measure: Perceived wellbeing
timeFrame: Daily during 6-week intervention
measure: Hunger and Satiety
timeFrame: Daily during 6-week intervention
measure: Body weight
timeFrame: study start, and after 6 weeks
measure: Psychological questionnaires
timeFrame: Before and after the 6-week intervention, and at 3-months follow-up
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
References:
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.
citation: Rijnaarts I, de Roos NM, Wang T, Zoetendal EG, Top J, Timmer M, Bouwman EP, Hogenelst K, Witteman B, de Wit N. Increasing dietary fibre intake in healthy adults using personalised dietary advice compared with general advice: a single-blind randomised controlled trial. Public Health Nutr. 2021 Apr;24(5):1117-1128. doi: 10.1017/S1368980020002980. Epub 2020 Sep 18.