Stimulating Fiber Intake Via Personalized Dietary Advice (Vezel-UP)

January 19, 2021 updated by: Wageningen University

Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6703 HD
        • Wageningen University, Division of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PDA
Intervention group: receives the personalized dietary advice
Behavioral: PDA
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).
ACTIVE_COMPARATOR: Control
Receives the general advice (two flyers containing information about fiber intake)
Other: Control (no intervention)
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dietary fiber intake
Time Frame: Before study, after 6 weeks intervention, and 3 months follow-up
Will be measured using the Food Frequency Questionnaire, and 24hr recalls to compute grams of fiber.
Before study, after 6 weeks intervention, and 3 months follow-up
change in Short Chain Fatty acid level
Time Frame: Before study, at 3 weeks and at 6 weeks
of a fecal sample
Before study, at 3 weeks and at 6 weeks
change in Microbiota composition
Time Frame: Before study, at 3 weeks and at 6 weeks
of a fecal sample
Before study, at 3 weeks and at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool pattern
Time Frame: Daily during 6-week intervention
Bristol stool chart en stool frequency
Daily during 6-week intervention
Perceived wellbeing
Time Frame: Daily during 6-week intervention
Using validated questions
Daily during 6-week intervention
Hunger and Satiety
Time Frame: Daily during 6-week intervention
Using validated questions
Daily during 6-week intervention
Body weight
Time Frame: study start, and after 6 weeks
Subjects weigh themselves (morning, fasted)
study start, and after 6 weeks
Psychological questionnaires
Time Frame: Before and after the 6-week intervention, and at 3-months follow-up
Validated questionnaire will be used to assess motives, barriers, knowledge, intentions, self-efficacy, self-regulation and knowledge
Before and after the 6-week intervention, and at 3-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Netherlands: Ministry of Health, Welfare and Sports
Kellogg Company
Sensus
Bolletje
Sonneveld
Dutch Association for Gastrointestinal diseases (MLDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

September 14, 2019

Study Completion (ACTUAL)

September 14, 2019

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL67998.028.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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