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NCT Number: NCT03848546

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Dietary Fiber Feeding Behavior Microbiota Personalized Advice

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, 6703 HD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PDA

Behavioral

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

Primary outcomes

  1. 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.

  2. change in Short Chain Fatty acid level

    Time frame: Before study, at 3 weeks and at 6 weeks

    of a fecal sample

  3. change in Microbiota composition

    Time frame: Before study, at 3 weeks and at 6 weeks

    of a fecal sample

Secondary outcomes

  1. Stool pattern

    Time frame: Daily during 6-week intervention

    Bristol stool chart en stool frequency

  2. Perceived wellbeing

    Time frame: Daily during 6-week intervention

    Using validated questions

  3. Hunger and Satiety

    Time frame: Daily during 6-week intervention

    Using validated questions

  4. Body weight

    Time frame: study start, and after 6 weeks

    Subjects weigh themselves (morning, fasted)

  5. 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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

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

Registry information

Official study title

Vezel-UP:Stimulating Fiber Intake Via Personalized Dietary Advice

Acronym: Vezel-UP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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