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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
146
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).
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).
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands
Microbiota diversity
Microbial richness (ASV) using 16s rRNA
Time frame: Baseline (week 0)
Microbiota diversity
Microbial richness (ASV) using 16s rRNA
Time frame: End ramp-up (week 2)
Microbiota diversity
Microbial richness (ASV) using 16s rRNA
Time frame: End intervention (week 8)
Gut microbiota composition
16s rRNA
Time frame: Baseline (week 0)
Gut microbiota composition
16s rRNA
Time frame: End ramp-up (week 2)
Gut microbiota composition
16s rRNA
Time frame: End intervention (week 8)
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time frame: Baseline (week 0)
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time frame: End ramp-up (week 2)
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time frame: End intervention (week 8)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
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).
Time frame: 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).
Time frame: 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).
Time frame: End intervention (week 8)
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time frame: Baseline (week 0)
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time frame: End ramp-up (week 2)
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time frame: End intervention (week 8)
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time frame: 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.
Time frame: Daily during intervention (week 0 - week 8)
Stool frequency
Frequency of bowel movement per day
Time frame: 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.
Time frame: Daily during intervention (week 0 - week 8)
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: Baseline (week 0)
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End ramp-up (week 2)
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End intervention (week 8)
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: Baseline (week 0)
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End ramp-up (week 2)
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End intervention (week 8)
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: Baseline (week 0)
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End ramp-up (week 2)
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End intervention (week 8)
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: Baseline (week 0)
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End ramp-up (week 2)
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time frame: End intervention (week 8)
Transit time
Using blue dye method (two blue muffins)
Time frame: Baseline (week 0)
Transit time
Using blue dye method (two blue muffins)
Time frame: End ramp-up (week 2)
Transit time
Using blue dye method (two blue muffins)
Time frame: End intervention (week 8)
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome.
Time frame: Baseline (week 0)
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time frame: End ramp-up (week 2)
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time frame: End intervention (week 8)
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: End follow-up (5 months)