Gut Health Enhancement by Eating Favourable Food
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 2
- Primary Endpoint
- Microbiota diversity
Study Overview
Brief Summary
Within the GEEF om je buik study the effects of an 8-week intervention with either a diet rich in fiber or fermented food on the gut microbiota will be investigated.
Detailed Description
This study is a randomized controlled trial (RCT) with three intervention groups (high dietary fiber group (HDF), high fermented foods group (HFF), and a control group (CG)). The total duration of the study is 5 months and consists of an 8-week intervention (2-week ramp up period with dietary guidelines, followed by 6-week period with dietary guidelines + additional consumption of study products) and a follow-up after 3 months. In total 147 subjects will be included.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
This study is partially blinded, study participants in the fiber and fermented group will be informed about their intervention after randomization. However, the control group will remain blind throughout the intervention period. Furthermore, participants are not made aware of the different types of intervention before start or during the intervention period. This is done to prevent any adjustments of their diets based on the advices in the other groups and to ensure that the control group stays blinded.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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, apart from the dietary advice in the study;
- •Having a smartphone compatible with the Lifedata or PocketQ app 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, rheumatoid arthritis, and 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 Body Mass Index (BMI) of ≥ 30 kg/m2 (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 weeks 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 soft or hard 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 WholeFiber, Keep Food Simple or at Cidrani;
- •Unable to follow or comply to study rules.
Outcomes
Primary Outcomes
Microbiota diversity
Time Frame: End intervention (week 8)
Microbial richness (ASV) using 16s rRNA
Secondary Outcomes
- Gut microbiota composition(End intervention (week 8))
- Dietary intake(End follow-up (5 months))
- Stool frequency(Daily during intervention (week 0 - week 8))
- Abundance of Prevotella(End intervention (week 8))
- Ratio of Prevotella/Bacteroides(End intervention (week 8))
- Well-being(End follow-up (5 months))
- Carbohydrate Active Enzymes (CAZymes)(End intervention (week 8))
- 92 inflammatory serum proteins(End intervention (week 8))
- Gastrointestinal complaints(Daily during intervention (week 0 - week 8))
- Intention to stay healthy (perception + awareness)(End follow-up (5 months))
- Stool consistency(Daily during intervention (week 0 - week 8))
- Abundance of Bacteroides(End intervention (week 8))
- Microbial alpha diversity(End intervention (week 8))
- Transit time(End intervention (week 8))
- Sleep quality(End follow-up (5 months))
- Digestion associated Quality of Life(End follow-up (5 months))
- Dietary intrinsic motivation (perception + awareness)(End follow-up (5 months))
- Dietary self-efficacy (perception + awareness)(End follow-up (5 months))
- Subjective health (perception and awareness)(End follow-up (5 months))
- Self-regulation (perception + awareness)(End follow-up (5 months))
- Subjective knowledge (perception + awareness)(End follow-up (5 months))
Investigators
Remco Kort
Professor doctor
VU University of Amsterdam