The primary objective is to investigate the effect of either a high fiber or fermented food intervention on the microbiota diversity indexcompared to control. Secondary objectives are the effect of either a high fiber or fermented food intervention…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Darmgezondheid, microbiota
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the microbiota diversity index
Secondary outcome
Secondary parameters are fecal microbiota composition, 92 immune markers,
gastrointestinal complaints (bloating, flatulence and abdominal pain), stool
frequency, stool consistency, transit time, quality of life, well-being, sleep
quality, fiber intake, fermented food intake, behavioural change and awareness.
Background summary
Gut microbiome homeostasis is important for maintaining overall human health.
Disturbances in the gut microbiota are associated with a number of medical
conditions and chronic diseases. Many chronic diseases are driven by chronic
inflammation, an immunological state that can be modulated by the gut
microbiome. Diet has emerged as a driving factor in microbiota composition and
function. The question remains whether there are dietary recommendations, that
can leverage extant host-microbiota interactions for improved health, across
broader populations.
Study objective
The primary objective is to investigate the effect of either a high fiber or
fermented food intervention on the microbiota diversity indexcompared to
control. Secondary objectives are the effect of either a high fiber or
fermented food intervention on fecal microbiota composition, immune markers,
gastrointestinal complaints, stool pattern, transit time, Quality of Life,
well-being and sleep quality. Additionally, the effect of a dietary advice
using recipe booklets and daily reminders will be investigated on dietary fiber
and fermented food intake and long-term behavioural change and awareness.
Tertiary, we will look into the effect of a diet high in fiber and fermented
food on body weight.
Study design
The study applies a randomized, parallel design of 8 weeks intervention and a
follow-up after 3 months.
Intervention
The study consist of three arms: 1) an intervention high in fiber, 2) an
intervention high in fermented foods, 3) a control group. All 3 arms receive a
link towards the website of MLDS and Voedingscentrum, with information about
diets and microbiota. The fiber arm receives 8 weeks dietary advice, based on
recipe booklet. Additionally, this group receives three times a day 3.3 gram of
WholeFiber product for 6 weeks (after 2 weeks ramp-up with use of the recipe
booklets). The fermented food arm receives 8 weeks dietary advice, based on a
recipe booklet, in which they are recommended to use 3 servings of fermented
food a day. Additionally, after 2 weeks ramp-up using this recipe booklet,
study participants receive three times a day 19 ml Kombucha. The control arm
receives the link towards the website of MLDS and Voedingscentrum.
Additionally, after 2 weeks ramp-up, they receive three times a day 3.3 gram of
maltodextrin for 6 weeks.
Study burden and risks
Study participants have to invest about 30 hours of their time in this study,
mainly to complete questionnaires (daily, weekly and 4 times a more extensive
questionnaire). On three timepoints they need to record their food intake for 3
days and they need to collect a fecal sample and a dried blood sample via a
fingerprick. Additionally, on these three timepoints study participants have to
make a picture of their fecal smear and to consume two blue muffins to measure
transit time. Furthermore, study participants have to consume an intervention
product 3 times a day for 6 weeks and are asked to follow dietary
recommendations for 8 weeks. The dietary recommendations include the
consumption of recipes from a recipe booklet (fiber group), consumption of 3
serveings of fermented food a day (fermented group), visit a website of MLDS
and Voedingscentrum and follow the recommendations on website (control group).
There are minor risk for the participants of this study.
De Boelelaan 1108
Amsterdam 1081HZ
NL
De Boelelaan 1108
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- Men and women, aged >=18 - <=70 years;
- Being able to read and speak Dutch
- Willing to keep a stable dietary pattern throughout the study;
- Having a smartphone to fill out the daily questionnaires.
Exclusion criteria
- Having a disease or medical condition which can influence the study results
such as diabetes, cancer, diagnosed irritable bowel syndrome, renal disease,
liver enzyme abnormality, malignant neoplasm, or a history of inflammatory
diseases (such as multiple sclerosis and rheumatoid arthritis inflammatory
bowel disease);
- Having a history of intestinal surgery that might interfere with study
outcomes (this does not include an appendectomy or cholecystectomy);
- Average dietary fiber intake of >=18 gram (women) or >=22 gram (men) per day,
according to the fiber screen questionnaire (see F1 questionnaires);
- More than 3 servings of fermented foods per day as assessed with the
fermented food frequency questionnaire (see F1 questionnaires);
- Having a BMI >= 30 (self-reported);
- Currently following a strict diet and unwilling or unable to change; for
example, a gluten free diet or a *crash diet* using meal substitutes;
- Specific food allergies that interfere with dietary intervention (for
example, gluten, lactose, etc);
- Use of prebiotics, probiotics and/or synbiotics (this should be stopped 4
week before the start of the study) and use of fiber supplements;
- Use of antibiotic treatment less than 3 months before start of the study
and/or use of antibiotics during the study;
- Use of medication that can interfere with the study outcomes, as judged by
the medical supervisor;
- Alcoholic use of >=14 (women) or >=28 (men) glasses of alcoholic beverages per
week;
- Use of drugs (should be stopped at least 4 weeks before start of the study);
- Being pregnant or lactating;
- Participation in another clinical trial at the same time;
- Student or employee working at either Food, Health and Consumer Research from
Wageningen Food and Biobased Research, Microbiology at VU, the MLDS, at Whole
Fibre, Keep Food Simple or at Cidrani;
- Unable to follow or comply to study rules
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 | NL83652.028.23 |