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Stimulating Fiber Intake Via Personalized Dietary Advice

Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848546
Acronym
Vezel-UP
Enrollment
106
Registered
2019-02-20
Start date
2019-03-01
Completion date
2019-09-14
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Fiber, Dietary Habits, Microbiota, Personalized Advice

Keywords

fiber intake, personalized dietary advice, stool pattern, perceived wellbeing

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.

Interventions

BEHAVIORALPDA

Subjects receive personal dietary fiber advice to increase their fiber intake. This advice will be provided using an online web-portal, where subjects can choose high-fiber alternatives that closely match their own intake. The aim is to swap product for low in fiber for a high fiber alternative (such as white bread, whole wheat bread).

OTHERControl (no intervention)

No intervention

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
Dutch Association for Gastrointestinal diseases (MLDS)
CollaboratorUNKNOWN
Bolletje
CollaboratorUNKNOWN
Sensus
CollaboratorINDUSTRY
Sonneveld
CollaboratorUNKNOWN
Kellogg Company
CollaboratorINDUSTRY
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Two groups: one receives general advice (control), the other personalized advice (intervention). Subjects are followed over time.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in dietary fiber intakeBefore study, after 6 weeks intervention, and 3 months follow-upWill be measured using the Food Frequency Questionnaire, and 24hr recalls to compute grams of fiber.
change in Short Chain Fatty acid levelBefore study, at 3 weeks and at 6 weeksof a fecal sample
change in Microbiota compositionBefore study, at 3 weeks and at 6 weeksof a fecal sample

Secondary

MeasureTime frameDescription
Hunger and SatietyDaily during 6-week interventionUsing validated questions
Psychological questionnairesBefore and after the 6-week intervention, and at 3-months follow-upValidated questionnaire will be used to assess motives, barriers, knowledge, intentions, self-efficacy, self-regulation and knowledge
Body weightstudy start, and after 6 weeksSubjects weigh themselves (morning, fasted)
Stool patternDaily during 6-week interventionBristol stool chart en stool frequency
Perceived wellbeingDaily during 6-week interventionUsing validated questions

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026