Skip to content

Gut health Enhancement by Eating Favourable Food

Gut health Enhancement by Eating Favourable Food - Care about your gastrointestinal tract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56340
Enrollment
147
Registered
2023-03-14
Start date
2023-05-10
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Darmgezondheid, microbiota gut health Microbiota

Interventions

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 Voedingsc

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Men and women, aged >=18 -

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The main study parameter is the microbiota diversity index

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)