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| Name | Class |
|---|---|
| Wageningen University and Research | OTHER |
| Maag Lever Darm Stichting | OTHER |
| Cidrani | UNKNOWN |
| WholeFiber |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber arm | Experimental | 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. |
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| Fermented food arm | Experimental | 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. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WholeFiber | Dietary Supplement | 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 + 2 snacks per day. 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota diversity | Microbial richness (ASV) using 16s rRNA | Baseline (week 0) |
| Microbiota diversity | Microbial richness (ASV) using 16s rRNA | End ramp-up (week 2) |
| Microbiota diversity | Microbial richness (ASV) using 16s rRNA | End intervention (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition | 16s rRNA | Baseline (week 0) |
| Gut microbiota composition | 16s rRNA | End ramp-up (week 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | Baseline (week 0) |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole de Wit, PhD | Wageningen Food and Biobased Research | Principal Investigator |
| Remco Kort, PhD | VU University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Wageningen Research | Wageningen | Gelderland | 6708 WG | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32210176 | Background | 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. | |
| 32232406 | Background | 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. |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068858 | Kombucha Tea |
| ID | Term |
|---|---|
| D013662 | Tea |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| UNKNOWN |
| Keep Food Simple | UNKNOWN |
The study applies a randomized, parallel design of 8 weeks (+ follow-up after 3 months)
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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.
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| Kombucha | Dietary Supplement | 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). |
|
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| Maltodextrin DE19/21 | Dietary Supplement | 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). |
|
| Gut microbiota composition | 16s rRNA | End intervention (week 8) |
| Carbohydrate Active Enzymes (CAZymes) | Relative abundance of CAZymes using shotgun metagenomic sequencing | Baseline (week 0) |
| Carbohydrate Active Enzymes (CAZymes) | Relative abundance of CAZymes using shotgun metagenomic sequencing | End ramp-up (week 2) |
| Carbohydrate Active Enzymes (CAZymes) | Relative abundance of CAZymes using shotgun metagenomic sequencing | End intervention (week 8) |
| 92 inflammatory serum proteins | 92 protein biomarkers proteins associated with inflammatory and immune response processes measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX). | Baseline (week 0) |
| 92 inflammatory serum proteins | 92 protein biomarkers proteins associated with inflammatory and immune response processes measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX). | End ramp-up (week 2) |
| 92 inflammatory serum proteins | 92 protein biomarkers proteins associated with inflammatory and immune response processes measured in dried blood spots using the Olink target 96 panels. Expressed as normalized protein expression (NPX). | End intervention (week 8) |
| Dietary intake | Average intake of fiber, fermented foods and macronutrients using the Traqq app | Baseline (week 0) |
| Dietary intake | Average intake of fiber, fermented foods and macronutrients using the Traqq app | End ramp-up (week 2) |
| Dietary intake | Average intake of fiber, fermented foods and macronutrients using the Traqq app | End intervention (week 8) |
| Dietary intake | Average intake of fiber, fermented foods and macronutrients using the Traqq app | End follow-up (5 months) |
| Gastrointestinal complaints | Likert-point scale (scores 0 - 10), for bloating, flatulence and abdominal pain. A higher score means more bloating, flatulence and abdominal pain. | Daily during intervention (week 0 - week 8) |
| Stool frequency | Frequency of bowel movement per day | Daily during intervention (week 0 - week 8) |
| Stool consistency | Consistency per stool, based on Bristol Stool Score (type 1 -7). Scores 1-7. A higher score means more loose / watery stool. | Daily during intervention (week 0 - week 8) |
| Abundance of Prevotella | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | Baseline (week 0) |
| Abundance of Prevotella | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End ramp-up (week 2) |
| Abundance of Prevotella | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End intervention (week 8) |
| Abundance of Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | Baseline (week 0) |
| Abundance of Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End ramp-up (week 2) |
| Abundance of Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End intervention (week 8) |
| Ratio of Prevotella/Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | Baseline (week 0) |
| Ratio of Prevotella/Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End ramp-up (week 2) |
| Ratio of Prevotella/Bacteroides | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End intervention (week 8) |
| Microbial alpha diversity | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | Baseline (week 0) |
| Microbial alpha diversity | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End ramp-up (week 2) |
| Microbial alpha diversity | Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning). | End intervention (week 8) |
| Transit time | Using blue dye method (two blue muffins) | Baseline (week 0) |
| Transit time | Using blue dye method (two blue muffins) | End ramp-up (week 2) |
| Transit time | Using blue dye method (two blue muffins) | End intervention (week 8) |
| Sleep quality | Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome. | Baseline (week 0) |
| Sleep quality | Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality. | End ramp-up (week 2) |
| Sleep quality | Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality. | End intervention (week 8) |
| Sleep quality | Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality. | End follow-up (5 months) |
| Digestion associated Quality of Life | Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life. | Baseline (week 0) |
| Digestion associated Quality of Life | Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life. | End ramp-up (week 2) |
| Digestion associated Quality of Life | Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life. | End intervention (week 8) |
| Digestion associated Quality of Life | Digestion associated Quality of Life (DQLQ) questionnaire. Score range: 0-9. Higher score indicates worse digestion associated quality of life. | End follow-up (5 months) |
| Well-being | 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. | Baseline (week 0) |
| Well-being | 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. | End ramp-up (week 2) |
| Well-being | 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. | End intervention (week 8) |
| Well-being | 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. | End follow-up (5 months) |
| Subjective health (perception and awareness) | 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 | Baseline (week 0) |
| Subjective health (perception and awareness) | 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 | End intervention (week 8) |
| Subjective health (perception and awareness) | 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 | End follow-up (5 months) |
| Intention to stay healthy (perception + awareness) | 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 | Baseline (week 0) |
| Intention to stay healthy (perception + awareness) | 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 | End intervention (week 8) |
| Intention to stay healthy (perception + awareness) | 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 | End follow-up (5 months) |
| Dietary intrinsic motivation (perception + awareness) | 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. | Baseline (week 0) |
| Dietary intrinsic motivation (perception + awareness) | 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. | End intervention (week 8) |
| Dietary intrinsic motivation (perception + awareness) | 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. | End follow-up (5 months) |
| Dietary self-efficacy (perception + awareness) | 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 | Baseline (week 0) |
| Dietary self-efficacy (perception + awareness) | 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 | End intervention (week 8) |
| Dietary self-efficacy (perception + awareness) | 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 | End follow-up (5 months) |
| Self-regulation (perception + awareness) | A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation | Baseline (week 0) |
| Self-regulation (perception + awareness) | A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation | End intervention (week 8) |
| Self-regulation (perception + awareness) | A 5-item questionnaire, which assesses the ability to plan and monitor actions. Score range: 5 - 35, higher scores mean a higher self-regulation | End follow-up (5 months) |
| Subjective knowledge (perception + awareness) | 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 | Baseline (week 0) |
| Subjective knowledge (perception + awareness) | 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 | End intervention (week 8) |
| Subjective knowledge (perception + awareness) | 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 | End follow-up (5 months) |
| End ramp-up (week 2) |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | End intervention (week 8) |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | End follow-up (5 months) |
| 34256014 | Result | 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. |
| 24336217 | Result | 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. |
| D000088082 |
| Fermented Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000074421 | Fermented Foods |
| D019602 | Food and Beverages |