NCT03848546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2019

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

January 22, 2019

Last Update Submit

January 19, 2021

Conditions

Dietary HabitsDietary FiberPersonalized AdviceMicrobiota

Keywords

fiber intakepersonalized dietary advicestool patternperceived wellbeing

Outcome Measures

Primary Outcomes (3)

  • Change in dietary fiber intake

    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

    of a fecal sample

    Before study, at 3 weeks and at 6 weeks

  • change in Microbiota composition

    of a fecal sample

    Before study, at 3 weeks and at 6 weeks

Secondary Outcomes (5)

  • Stool pattern

    Daily during 6-week intervention

  • Perceived wellbeing

    Daily during 6-week intervention

  • Hunger and Satiety

    Daily during 6-week intervention

  • Body weight

    study start, and after 6 weeks

  • Psychological questionnaires

    Before and after the 6-week intervention, and at 3-months follow-up

Study Arms (2)

PDA

EXPERIMENTAL

Intervention group: receives the personalized dietary advice

Behavioral: PDA

Control

ACTIVE COMPARATOR

Receives the general advice (two flyers containing information about fiber intake)

Other: Control (no intervention)

Interventions

PDABEHAVIORAL

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).

PDA
Control (no intervention)OTHER

No intervention

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.

You may not qualify if:

  • Relatively low fiber intake: which is assessed by a short fiber intake screening questionnaire (score ranging from
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, 6703 HD, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 34378249DERIVED

  • 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.

    PMID: 32943128DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups: one receives general advice (control), the other personalized advice (intervention). Subjects are followed over time.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 20, 2019

Study Start

March 1, 2019

Primary Completion

September 14, 2019

Study Completion

September 14, 2019

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)