Stimulating Fiber Intake Via Personalized Dietary Advice

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03848546
Study type	Interventional
Source	Wageningen University
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2019
Completion date	September 14, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stimulating Fiber Intake Via Personalized Dietary Advice — Vezel-UP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms