Clinical trial NCT05900609: Gut Health Enhancement by Eating Favourable Food
Official title: Gut Health Enhancement by Eating Favourable Food
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Microbial Colonization
Keywords: Fiber
Fermented food
Immune system
Microbiota
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
name: Maag Lever Darm Stichting
name: Cidrani
name: WholeFiber
name: Keep Food Simple
First posted: 2023-06-12
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study applies a randomized, parallel design of 8 weeks (+ follow-up after 3 months)
Primary purpose: PREVENTION

Brief summary: Within the GEEF om je buik study the effect of 8 weeks 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbiota diversity
timeFrame: Baseline (week 0)
measure: Microbiota diversity
timeFrame: End ramp-up (week 2)
measure: Microbiota diversity
timeFrame: End intervention (week 8)
Secondary outcomes:
measure: Gut microbiota composition
timeFrame: Baseline (week 0)
measure: Gut microbiota composition
timeFrame: End ramp-up (week 2)
measure: Gut microbiota composition
timeFrame: End intervention (week 8)
measure: Carbohydrate Active Enzymes (CAZymes)
timeFrame: Baseline (week 0)
measure: Carbohydrate Active Enzymes (CAZymes)
timeFrame: End ramp-up (week 2)
measure: Carbohydrate Active Enzymes (CAZymes)
timeFrame: End intervention (week 8)
measure: 92 inflammatory serum proteins
timeFrame: Baseline (week 0)
measure: 92 inflammatory serum proteins
timeFrame: End ramp-up (week 2)
measure: 92 inflammatory serum proteins
timeFrame: End intervention (week 8)
measure: Dietary intake
timeFrame: Baseline (week 0)
measure: Dietary intake
timeFrame: End ramp-up (week 2)
measure: Dietary intake
timeFrame: End intervention (week 8)
measure: Dietary intake
timeFrame: End follow-up (5 months)
measure: Gastrointestinal complaints
timeFrame: Daily during intervention (week 0 - week 8)
measure: Stool frequency
timeFrame: Daily during intervention (week 0 - week 8)
measure: Stool consistency
timeFrame: Daily during intervention (week 0 - week 8)
measure: Abundance of Prevotella
timeFrame: Baseline (week 0)
measure: Abundance of Prevotella
timeFrame: End ramp-up (week 2)
measure: Abundance of Prevotella
timeFrame: End intervention (week 8)
measure: Abundance of Bacteroides
timeFrame: Baseline (week 0)
measure: Abundance of Bacteroides
timeFrame: End ramp-up (week 2)
measure: Abundance of Bacteroides
timeFrame: End intervention (week 8)
measure: Ratio of Prevotella/Bacteroides
timeFrame: Baseline (week 0)
measure: Ratio of Prevotella/Bacteroides
timeFrame: End ramp-up (week 2)
measure: Ratio of Prevotella/Bacteroides
timeFrame: End intervention (week 8)
measure: Microbial alpha diversity
timeFrame: Baseline (week 0)
measure: Microbial alpha diversity
timeFrame: End ramp-up (week 2)
measure: Microbial alpha diversity
timeFrame: End intervention (week 8)
measure: Transit time
timeFrame: Baseline (week 0)
measure: Transit time
timeFrame: End ramp-up (week 2)
measure: Transit time
timeFrame: End intervention (week 8)
measure: Sleep quality
timeFrame: Baseline (week 0)
measure: Sleep quality
timeFrame: End ramp-up (week 2)
measure: Sleep quality
timeFrame: End intervention (week 8)
measure: Sleep quality
timeFrame: End follow-up (5 months)
measure: Digestion associated Quality of Life
timeFrame: Baseline (week 0)
measure: Digestion associated Quality of Life
timeFrame: End ramp-up (week 2)
measure: Digestion associated Quality of Life
timeFrame: End intervention (week 8)
measure: Digestion associated Quality of Life
timeFrame: End follow-up (5 months)
measure: Well-being
timeFrame: Baseline (week 0)
measure: Well-being
timeFrame: End ramp-up (week 2)
measure: Well-being
timeFrame: End intervention (week 8)
measure: Well-being
timeFrame: End follow-up (5 months)
measure: Subjective health (perception and awareness)
timeFrame: Baseline (week 0)
measure: Subjective health (perception and awareness)
timeFrame: End intervention (week 8)
measure: Subjective health (perception and awareness)
timeFrame: End follow-up (5 months)
measure: Intention to stay healthy (perception + awareness)
timeFrame: Baseline (week 0)
measure: Intention to stay healthy (perception + awareness)
timeFrame: End intervention (week 8)
measure: Intention to stay healthy (perception + awareness)
timeFrame: End follow-up (5 months)
measure: Dietary intrinsic motivation (perception + awareness)
timeFrame: Baseline (week 0)
measure: Dietary intrinsic motivation (perception + awareness)
timeFrame: End intervention (week 8)
measure: Dietary intrinsic motivation (perception + awareness)
timeFrame: End follow-up (5 months)
measure: Dietary self-efficacy (perception + awareness)
timeFrame: Baseline (week 0)
measure: Dietary self-efficacy (perception + awareness)
timeFrame: End intervention (week 8)
measure: Dietary self-efficacy (perception + awareness)
timeFrame: End follow-up (5 months)
measure: Self-regulation (perception + awareness)
timeFrame: Baseline (week 0)
measure: Self-regulation (perception + awareness)
timeFrame: End intervention (week 8)
measure: Self-regulation (perception + awareness)
timeFrame: End follow-up (5 months)
measure: Subjective knowledge (perception + awareness)
timeFrame: Baseline (week 0)
measure: Subjective knowledge (perception + awareness)
timeFrame: End intervention (week 8)
measure: Subjective knowledge (perception + awareness)
timeFrame: End follow-up (5 months)
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline (week 0)
measure: Body Mass Index (BMI)
timeFrame: End ramp-up (week 2)
measure: Body Mass Index (BMI)
timeFrame: End intervention (week 8)
measure: Body Mass Index (BMI)
timeFrame: End follow-up (5 months)
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen Food and Biobased Research
name: Nicole de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University of Amsterdam
name: Remco Kort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myhrstad MCW, Tunsjo H, Charnock C, Telle-Hansen VH. Dietary Fiber, Gut Microbiota, and Metabolic Regulation-Current Status in Human Randomized Trials. Nutrients. 2020 Mar 23;12(3):859. doi: 10.3390/nu12030859.
citation: Stiemsma LT, Nakamura RE, Nguyen JG, Michels KB. Does Consumption of Fermented Foods Modify the Human Gut Microbiota? J Nutr. 2020 Jul 1;150(7):1680-1692. doi: 10.1093/jn/nxaa077.
citation: Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.
citation: David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.