Gut health Enhancement by Eating Favourable Food
- Conditions
- Darmgezondheid, microbiotagut healthMicrobiota
- Registration Number
- NL-OMON56340
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 147
- 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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the microbiota diversity index </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are fecal microbiota composition, 92 immune markers,<br />gastrointestinal complaints (bloating, flatulence and abdominal pain), stool<br />frequency, stool consistency, transit time, quality of life, well-being, sleep<br />quality, fiber intake, fermented food intake, behavioural change and awareness. </p>