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 (…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal conditions NEC
Synonym
Health condition
In ogenschijnlijk gezonde mensen (met een lage vezelinname) wordt gekeken of gepersonaliseerd voedingsadvies daadwerkelijk leidt tot een verhoogde vezelinname. Daaraan gekoppeld wordt gekeken of stoelgang en welbevinden verbetert, maar dit zijn niet de primaire uitkomstmaten.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background 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.
Study objective
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, 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.
Intervention
The intervention group receives personalized dietary advice (PDA) based on
their current food pattern, preferences and self-regulation 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 web-portal. 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 burden and risks
This study has a negligible risk for subjects, and the burden of the study is
in line with possible gains for the subjects. The PDA aims to follow the
national dietary guidelines from the Netherlands Nutrition Center and is based
on personal preferences. Moreover, all foods and drinks that are advised as
fiber-rich alternatives are commercially available, and therefore safe for
consumption.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67998.028.18 |