Dietary HabitsVezel-UPNCT03848546

Stimulating Fiber Intake Via Personalized Dietary Advice

A study testing PDA in people with Dietary Habits and Dietary Fiber, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dietary Habits, Dietary Fiber, Personalized Advice
What is being tested?: PDA
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteNetherlands
Study dates: 1 Mar 2019to 14 Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Wageningen University, Division of Human Nutrition
Wageningen, 6703 HD

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions: Dietary Habits, Dietary Fiber, Personalized Advice, Microbiota
Being tested: PDA, Control (no intervention)
Keywords: fiber intake, personalized dietary advice, stool pattern, perceived wellbeing
Medical subject headings: Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PDABehavioural
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).
Control (no intervention)Other
No intervention

Study groups in NCT03848546
Study group	Role	What they receive
PDA	Experimental	Intervention group: receives the personalized dietary advice Receives: Behavioral: PDA
Control	Active comparator	Receives the general advice (two flyers containing information about fiber intake) Receives: Other: Control (no intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201914 Sep 2019

First posted20 Feb 2019
Study start1 Mar 2019
Primary completion14 Sep 2019
Study completion14 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dietary HabitsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two groups: one receives general advice (control), the other personalized advice (intervention). Subjects are followed over time.
Masking: Single blind
Who is masked: Participant
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03848546
Sponsor's protocol ID: NL67998.028.18
Acronym: Vezel-UP
Status last verified: Jan 2021
First submitted: 22 Jan 2019
Last updated: 22 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34378249
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.
PubMed 32943128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice
ClinicalTrials.gov ID: NCT03848546
Acronym / sponsor ID: Vezel-UP / NL67998.028.18
Conditions: Dietary Habits, Dietary Fiber, Personalized Advice, Microbiota
Keywords: fiber intake, personalized dietary advice, stool pattern, perceived wellbeing
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Wageningen UniversityUniversity, hospital or other
Collaborators: Netherlands: Ministry of Health, Welfare and Sports, Dutch Association for Gastrointestinal diseases (MLDS), Bolletje, Sensus, Sonneveld, Kellogg Company
Study start: 1 Mar 2019 (actual)
Primary completion: 14 Sep 2019 (actual)
Study completion: 14 Sep 2019 (actual)
First posted: 20 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Two groups: one receives general advice (control), the other personalized advice (intervention). Subjects are followed over time.

Arm	Type	Receives
PDA	Experimental	Behavioral: PDAIntervention group: receives the personalized dietary advice
Control	Active comparator	Other: Control (no intervention)Receives the general advice (two flyers containing information about fiber intake)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDASubjects 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).	Behavioural	PDA
Control (no intervention)No intervention	Other	Control

Primary outcome

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.
change in Short Chain Fatty acid level
Time frame: Before study, at 3 weeks and at 6 weeks
of a fecal sample
change in Microbiota composition
Time frame: Before study, at 3 weeks and at 6 weeks
of a fecal sample

5 secondary outcomes

Stool pattern
Time frame: Daily during 6-week intervention
Perceived wellbeing
Time frame: Daily during 6-week intervention
Hunger and Satiety
Time frame: Daily during 6-week intervention
Body weight
Time frame: study start, and after 6 weeks
Psychological questionnaires
Time frame: Before and after the 6-week intervention, and at 3-months follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Derived from this study: PubMed 34378249Rijnaarts 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.
Derived from this study: PubMed 32943128Rijnaarts 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PDA in people with Dietary Habits and Dietary Fiber, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dietary fiber intake (time frame: Before study, after 6 weeks intervention, and 3 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03848546, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.