GEEFomjebuik: Gut Health Enhancement by Eating Favourable Food
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fiber arm Subjects receive dietary guidelines, to increase their fiber intake. Additionally, during the last 6 weeks of the intervention period subjects receive a study product containing 8,5 grams fiber per day. Additionally, subjects receive general guidelines about the effect of nutrition on the gut microbiome. |
Dietary Supplement: WholeFiber
WholeFiberTM is a product with high levels of prebiotic dietary fibers (~85%) mainly consisting of inulin, and some pectin, hemi-cellulose and cellulose that is derived from the root vegetable, chicory roots.
Fiber guidelines:
Subjects receive a booklet with recipes high in fiber. Subjects are recommended to use 2 recipes per day + a snack. Estimated average intake via the recipes in the recipe booklet is 24 grams/day.
General guidelines on nutrition and microbiome:
Subjects receive a link to a website with general recommendations to positively alter the gut microbiome (website Voedingscentrum and Dutch Digestive Foundation).
Other Names:
|
| Experimental: Fermented food arm Subjects receive dietary guidelines, to increase their intake of fermented foods. Additionally, during the last 6 weeks of the intervention period subjects receive a study product of 17 millilitres concentrated kombucha per day. Additionally, subjects receive general guidelines about the effect of nutrition on the gut microbiome. |
Dietary Supplement: Kombucha
The kombucha is produced by a minimum three-month long fermentation process. It is a live fermented herbal drink essence, without refined sugar, and an unpasteurized, organic product.
Fermented food guidelines:
Study participants in the fermented foods arm are asked to use 3 additional servings of fermented food per day, using the fermented food list / recipe booklet.
General guidelines on nutrition and microbiome:
Subjects receive a link to a website with general recommendations to positively alter the gut microbiome (website Voedingscentrum and Dutch Digestive Foundation).
Other Names:
|
| Placebo Comparator: Control Subjects receive general guidelines about the effect of nutrition on the gut microbiome. Additionally, during the last 6 weeks of the intervention period subjects receive a placebo product of 10 grams maltodextrin per day. |
Dietary Supplement: Maltodextrin DE19/21
Maltodextrin DE19/21 is a digestible carbohydrate, that is completely digested and does not reach the colon, which makes it a suitable placebo dietary compound and the reason why it is frequently used in comparable studies.
General guidelines on nutrition and microbiome:
Subjects receive a link to a website with general recommendations to positively alter the gut microbiome (website Voedingscentrum and Dutch Digestive Foundation).
|
Outcome Measures
Primary Outcome Measures
- Microbiota diversity [Baseline (week 0)]
Microbioal richness (ASV) using 16s rRNA
- Microbiota diversity [End ramp-up (week 2)]
Microbioal richness (ASV) using 16s rRNA
- Microbiota diversity [End intervention (week 8)]
Microbioal richness (ASV) using 16s rRNA
Secondary Outcome Measures
- Gut microbiota composition [Baseline (week 0)]
16s rRNA
- Gut microbiota composition [End ramp-up (week 2)]
16s rRNA
- Gut microbiota composition [End intervention (week 8)]
16s rRNA
- Carbohydrate Active Enzymes (CAZymes) [Baseline (week 0)]
Relative abundance of CAZymes using shotgun metagenomic sequencing
- Carbohydrate Active Enzymes (CAZymes) [End ramp-up (week 2)]
Relative abundance of CAZymes using shotgun metagenomic sequencing
- Carbohydrate Active Enzymes (CAZymes) [End intervention (week 8)]
Relative abundance of CAZymes using shotgun metagenomic sequencing
- 92 inflammatory serum proteins [Baseline (week 0)]
92 immune markers, including circulating cytokine levels, cell-specific cytokine response signaling, and cell frequency and immune cell signaling at steady-state, measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX).
- 92 inflammatory serum proteins [End ramp-up (week 2)]
92 immune markers, including circulating cytokine levels, cell-specific cytokine response signaling, and cell frequency and immune cell signaling at steady-state, measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX).
- 92 inflammatory serum proteins [End intervention (week 8)]
92 immune markers, including circulating cytokine levels, cell-specific cytokine response signaling, and cell frequency and immune cell signaling at steady-state, measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX).
- Dietary intake [Baseline (week 0)]
Average intake of fiber, fermented foods and macronutrients using the Traqq app
- Dietary intake [End ramp-up (week 2)]
Average intake of fiber, fermented foods and macronutrients using the Traqq app
- Dietary intake [End intervention (week 8)]
Average intake of fiber, fermented foods and macronutrients using the Traqq app
- Dietary intake [End follow-up (5 months)]
Average intake of fiber, fermented foods and macronutrients using the Traqq app
- Gastrointestinal complaints [Daily during intervention (week 0 - week 8)]
Likert-point scale (scores 0 - 10), for bloating, flatulence and abdominal pain. A higher score means more bloating, flatulence and abdominal pain.
- Stool frequency [Daily during intervention (week 0 - week 8)]
Frequency of bowel movement per day
- Stool consistency [Daily during intervention (week 0 - week 8)]
Consistency per stool, based on Bristol Stool Score (type 1 -7)
- Abundance of Prevotella [Baseline (week 0)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Abundance of Prevotella [End ramp-up (week 2)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Abundance of Prevotella [End intervention (week 8)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Abundance of Bacteroides [Baseline (week 0)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Abundance of Bacteroides [End ramp-up (week 2)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Abundance of Bacteroides [End intervention (week 8)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Ratio of Prevotella/Bacteroides [Baseline (week 0)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Ratio of Prevotella/Bacteroides [End ramp-up (week 2)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Ratio of Prevotella/Bacteroides [End intervention (week 8)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Microbial alpha diversity [Baseline (week 0)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Microbial alpha diversity [End ramp-up (week 2)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Microbial alpha diversity [End intervention (week 8)]
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
- Transit time [Baseline (week 0)]
Using blue dye method (two blue muffins)
- Transit time [End ramp-up (week 2)]
Using blue dye method (two blue muffins)
- Transit time [End intervention (week 8)]
Using blue dye method (two blue muffins)
- Sleep quality [Baseline (week 0)]
Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome.
- Sleep quality [End ramp-up (week 2)]
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
- Sleep quality [End intervention (week 8)]
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
- Sleep quality [End follow-up (5 months)]
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
- Digestion associated Quality of Life [Baseline (week 0)]
Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life.
- Digestion associated Quality of Life [End ramp-up (week 2)]
Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life.
- Digestion associated Quality of Life [End intervention (week 8)]
Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life.
- Digestion associated Quality of Life [End follow-up (5 months)]
Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life.
- Well-being [Baseline (week 0)]
World Health Organisation (WHO)-Five Well-Being Index (WHO-5) questionnaire. Raw score ranges from 0-25. Final score is calculated by multiplying the raw score by 4. Final score range 0-100. Higher score indicates better well-being.
- Well-being [End ramp-up (week 2)]
World Health Organisation (WHO)-Five Well-Being Index (WHO-5) questionnaire. Raw score ranges from 0-25. Final score is calculated by multiplying the raw score by 4. Final score range 0-100. Higher score indicates better well-being.
- Well-being [End intervention (week 8)]
World Health Organisation (WHO)-Five Well-Being Index (WHO-5) questionnaire. Raw score ranges from 0-25. Final score is calculated by multiplying the raw score by 4. Final score range 0-100. Higher score indicates better well-being.
- Well-being [End follow-up (5 months)]
World Health Organisation (WHO)-Five Well-Being Index (WHO-5) questionnaire. Raw score ranges from 0-25. Final score is calculated by multiplying the raw score by 4. Final score range 0-100. Higher score indicates better well-being.
- Subjective health (perception and awareness) [Baseline (week 0)]
A 2-item questionnaire, which assesses how healthy participants perceive their own health and diet. Score range: 2 - 14, higher scores mean a higher subjective health
- Subjective health (perception and awareness) [End intervention (week 8)]
A 2-item questionnaire, which assesses how healthy participants perceive their own health and diet. Score range: 2 - 14, higher scores mean a higher subjective health
- Subjective health (perception and awareness) [End follow-up (5 months)]
A 2-item questionnaire, which assesses how healthy participants perceive their own health and diet. Score range: 2 - 14, higher scores mean a higher subjective health
- Intention to stay healthy (perception + awareness) [Baseline (week 0)]
A 3-item questionnaire, which assesses the extent to which participants have the intention to eat healthy. Score range: 3 - 21, higher scores mean more intention to stay healthy
- Intention to stay healthy (perception + awareness) [End intervention (week 8)]
A 3-item questionnaire, which assesses the extent to which participants have the intention to eat healthy. Score range: 3 - 21, higher scores mean more intention to stay healthy
- Intention to stay healthy (perception + awareness) [End follow-up (5 months)]
A 3-item questionnaire, which assesses the extent to which participants have the intention to eat healthy. Score range: 3 - 21, higher scores mean more intention to stay healthy
- Dietary intrinsic motivation (perception + awareness) [Baseline (week 0)]
A validated 6-item questionnaire, which assesses whether someone's motivation to eat healthy comes from within a person. Score range: 6 - 42, higher scores mean a higher intrinsic motivation.
- Dietary intrinsic motivation (perception + awareness) [End intervention (week 8)]
A validated 6-item questionnaire, which assesses whether someone's motivation to eat healthy comes from within a person. Score range: 6 - 42, higher scores mean a higher intrinsic motivation.
- Dietary intrinsic motivation (perception + awareness) [End follow-up (5 months)]
A validated 6-item questionnaire, which assesses whether someone's motivation to eat healthy comes from within a person. Score range: 6 - 42, higher scores mean a higher intrinsic motivation.
- Dietary self-efficacy (perception + awareness) [Baseline (week 0)]
A validated 8-item questionnaire, which assesses the extent to which one feels capable of eating healthy. Score range: 8 - 49, higher scores mean a higher self-efficacy
- Dietary self-efficacy (perception + awareness) [End intervention (week 8)]
A validated 8-item questionnaire, which assesses the extent to which one feels capable of eating healthy. Score range: 8 - 49, higher scores mean a higher self-efficacy
- Dietary self-efficacy (perception + awareness) [End follow-up (5 months)]
A validated 8-item questionnaire, which assesses the extent to which one feels capable of eating healthy. Score range: 8 - 49, higher scores mean a higher self-efficacy
- Self-regulation (perception + awareness) [Baseline (week 0)]
A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation
- Self-regulation (perception + awareness) [End intervention (week 8)]
A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation
- Self-regulation (perception + awareness) [End follow-up (5 months)]
A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation
- Subjective knowledge (perception + awareness) [Baseline (week 0)]
A validated 5-item questionnaire, which assesses how knowledgeable someone feels about nutrition and gut microbiota. Score range: 5 - 35, higher scores mean a higher subjective knowledge
- Subjective knowledge (perception + awareness) [End intervention (week 8)]
A validated 5-item questionnaire, which assesses how knowledgeable someone feels about nutrition and gut microbiota. Score range: 5 - 35, higher scores mean a higher subjective knowledge
- Subjective knowledge (perception + awareness) [End follow-up (5 months)]
A validated 5-item questionnaire, which assesses how knowledgeable someone feels about nutrition and gut microbiota. Score range: 5 - 35, higher scores mean a higher subjective knowledge
Other Outcome Measures
- Body Mass Index (BMI) [Baseline (week 0)]
Weight and height will be combined to report BMI in kg/m^2
- Body Mass Index (BMI) [End ramp-up (week 2)]
Weight and height will be combined to report BMI in kg/m^2
- Body Mass Index (BMI) [End intervention (week 8)]
Weight and height will be combined to report BMI in kg/m^2
- Body Mass Index (BMI) [End follow-up (5 months)]
Weight and height will be combined to report BMI in kg/m^2
Eligibility Criteria
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);
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Having a history of intestinal surgery that might interfere with study outcomes (this does not include an appendectomy or cholecystectomy);
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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);
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Having a Body Mass Index (BMI) of ≥ 30 kg/m2 (self-reported);
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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);
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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;
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Use of medication that can interfere with the study outcomes, as judged by the medical supervisor;
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Alcoholic use of ≥14 (women) or ≥28 (men) glasses of alcoholic beverages per week;
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Use of soft or hard drugs (should be stopped at least 4 weeks before start of the study);
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Being pregnant or lactating;
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Participation in another clinical trial at the same time;
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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;
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Unable to follow or comply to study rules.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stichting Wageningen Research | Wageningen | Gelderland | Netherlands | 6708 WG |
Sponsors and Collaborators
- VU University of Amsterdam
- Wageningen University and Research
- Maag Lever Darm Stichting
- Cidrani
- WholeFiber
- Keep Food Simple
Investigators
- Principal Investigator: Nicole de Wit, PhD, Wageningen Food and Biobased Research
- Principal Investigator: Remco Kort, PhD, VU University of Amsterdam
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- NL83652.028.23