Stimulating Fiber Intake Via Personalized Dietary Advice

NCT03848546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Dietary Habits
  • Dietary Fiber
  • Personalized Advice
  • Microbiota

Interventions

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).

OTHER

Control (no intervention)

No intervention

Sponsors & Collaborators

  • Netherlands: Ministry of Health, Welfare and Sports

    collaborator OTHER_GOV
  • Dutch Association for Gastrointestinal diseases (MLDS)

    collaborator UNKNOWN
  • Bolletje

    collaborator UNKNOWN
  • Sensus

    collaborator INDUSTRY
  • Sonneveld

    collaborator UNKNOWN
  • Kellogg Company

    collaborator INDUSTRY
  • Wageningen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-09-14
Completion
2019-09-14

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848546 on ClinicalTrials.gov