Back to resultsGut Health Enhancement by Eating Favourable Food (GEEFomjebuik)
Primary Purpose
Microbial Colonization
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
WholeFiber
Kombucha
Maltodextrin DE19/21
Sponsored by
About this trial
This is an interventional prevention trial for Microbial Colonization focused on measuring Fiber, Fermented food, Immune system, Microbiota
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.
Sites / Locations
- Stichting Wageningen ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Fiber arm
Fermented food arm
Control
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Microbiota diversity
Microbioal richness (ASV) using 16s rRNA
Microbiota diversity
Microbioal richness (ASV) using 16s rRNA
Microbiota diversity
Microbioal richness (ASV) using 16s rRNA
Secondary Outcome Measures
Gut microbiota composition
16s rRNA
Gut microbiota composition
16s rRNA
Gut microbiota composition
16s rRNA
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
Carbohydrate Active Enzymes (CAZymes)
Relative abundance of CAZymes using shotgun metagenomic sequencing
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).
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).
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).
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Dietary intake
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Gastrointestinal complaints
Likert-point scale (scores 0 - 10), for bloating, flatulence and abdominal pain. A higher score means more bloating, flatulence and abdominal pain.
Stool frequency
Frequency of bowel movement per day
Stool consistency
Consistency per stool, based on Bristol Stool Score (type 1 -7). Scores 1-7. A higher score means more loose / watery stool.
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Abundance of Prevotella
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Abundance of Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Ratio of Prevotella/Bacteroides
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Microbial alpha diversity
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Transit time
Using blue dye method (two blue muffins)
Transit time
Using blue dye method (two blue muffins)
Transit time
Using blue dye method (two blue muffins)
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome.
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Sleep quality
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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.
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.
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.
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05900609
First Posted
April 3, 2023
Last Updated
September 7, 2023
Sponsor
VU University of Amsterdam
Collaborators
Wageningen University and Research, Maag Lever Darm Stichting, Cidrani, WholeFiber, Keep Food Simple
1. Study Identification
Unique Protocol Identification Number
NCT05900609
Brief Title
Gut Health Enhancement by Eating Favourable Food
Acronym
GEEFomjebuik
Official Title
Gut Health Enhancement by Eating Favourable Food
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
Wageningen University and Research, Maag Lever Darm Stichting, Cidrani, WholeFiber, Keep Food Simple
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
Fiber, Fermented food, Immune system, Microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study applies a randomized, parallel design of 8 weeks (+ follow-up after 3 months)
Masking
None (Open Label)
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.
Allocation
Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fiber arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Fermented food arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
WholeFiber
Other Intervention Name(s)
Chicory roots
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Kombucha
Other Intervention Name(s)
Fermented tea
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin DE19/21
Intervention Description
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).
Primary Outcome Measure Information:
Title
Microbiota diversity
Description
Microbioal richness (ASV) using 16s rRNA
Time Frame
Baseline (week 0)
Title
Microbiota diversity
Description
Microbioal richness (ASV) using 16s rRNA
Time Frame
End ramp-up (week 2)
Title
Microbiota diversity
Description
Microbioal richness (ASV) using 16s rRNA
Time Frame
End intervention (week 8)
Secondary Outcome Measure Information:
Title
Gut microbiota composition
Description
16s rRNA
Time Frame
Baseline (week 0)
Title
Gut microbiota composition
Description
16s rRNA
Time Frame
End ramp-up (week 2)
Title
Gut microbiota composition
Description
16s rRNA
Time Frame
End intervention (week 8)
Title
Carbohydrate Active Enzymes (CAZymes)
Description
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time Frame
Baseline (week 0)
Title
Carbohydrate Active Enzymes (CAZymes)
Description
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time Frame
End ramp-up (week 2)
Title
Carbohydrate Active Enzymes (CAZymes)
Description
Relative abundance of CAZymes using shotgun metagenomic sequencing
Time Frame
End intervention (week 8)
Title
92 inflammatory serum proteins
Description
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)
Title
92 inflammatory serum proteins
Description
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)
Title
92 inflammatory serum proteins
Description
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)
Title
Dietary intake
Description
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time Frame
Baseline (week 0)
Title
Dietary intake
Description
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time Frame
End ramp-up (week 2)
Title
Dietary intake
Description
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time Frame
End intervention (week 8)
Title
Dietary intake
Description
Average intake of fiber, fermented foods and macronutrients using the Traqq app
Time Frame
End follow-up (5 months)
Title
Gastrointestinal complaints
Description
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)
Title
Stool frequency
Description
Frequency of bowel movement per day
Time Frame
Daily during intervention (week 0 - week 8)
Title
Stool consistency
Description
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)
Title
Abundance of Prevotella
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
Baseline (week 0)
Title
Abundance of Prevotella
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End ramp-up (week 2)
Title
Abundance of Prevotella
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End intervention (week 8)
Title
Abundance of Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
Baseline (week 0)
Title
Abundance of Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End ramp-up (week 2)
Title
Abundance of Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End intervention (week 8)
Title
Ratio of Prevotella/Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
Baseline (week 0)
Title
Ratio of Prevotella/Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End ramp-up (week 2)
Title
Ratio of Prevotella/Bacteroides
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End intervention (week 8)
Title
Microbial alpha diversity
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
Baseline (week 0)
Title
Microbial alpha diversity
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End ramp-up (week 2)
Title
Microbial alpha diversity
Description
Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).
Time Frame
End intervention (week 8)
Title
Transit time
Description
Using blue dye method (two blue muffins)
Time Frame
Baseline (week 0)
Title
Transit time
Description
Using blue dye method (two blue muffins)
Time Frame
End ramp-up (week 2)
Title
Transit time
Description
Using blue dye method (two blue muffins)
Time Frame
End intervention (week 8)
Title
Sleep quality
Description
Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome.
Time Frame
Baseline (week 0)
Title
Sleep quality
Description
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time Frame
End ramp-up (week 2)
Title
Sleep quality
Description
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time Frame
End intervention (week 8)
Title
Sleep quality
Description
Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.
Time Frame
End follow-up (5 months)
Title
Digestion associated Quality of Life
Description
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)
Title
Digestion associated Quality of Life
Description
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)
Title
Digestion associated Quality of Life
Description
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)
Title
Digestion associated Quality of Life
Description
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)
Title
Well-being
Description
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)
Title
Well-being
Description
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)
Title
Well-being
Description
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)
Title
Well-being
Description
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)
Title
Subjective health (perception and awareness)
Description
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)
Title
Subjective health (perception and awareness)
Description
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)
Title
Subjective health (perception and awareness)
Description
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)
Title
Intention to stay healthy (perception + awareness)
Description
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)
Title
Intention to stay healthy (perception + awareness)
Description
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)
Title
Intention to stay healthy (perception + awareness)
Description
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)
Title
Dietary intrinsic motivation (perception + awareness)
Description
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)
Title
Dietary intrinsic motivation (perception + awareness)
Description
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)
Title
Dietary intrinsic motivation (perception + awareness)
Description
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)
Title
Dietary self-efficacy (perception + awareness)
Description
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)
Title
Dietary self-efficacy (perception + awareness)
Description
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)
Title
Dietary self-efficacy (perception + awareness)
Description
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)
Title
Self-regulation (perception + awareness)
Description
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)
Title
Self-regulation (perception + awareness)
Description
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)
Title
Self-regulation (perception + awareness)
Description
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)
Title
Subjective knowledge (perception + awareness)
Description
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)
Title
Subjective knowledge (perception + awareness)
Description
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)
Title
Subjective knowledge (perception + awareness)
Description
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)
Other Pre-specified Outcome Measures:
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline (week 0)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
End ramp-up (week 2)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
End intervention (week 8)
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
End follow-up (5 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maartje van den Belt, Msc
Phone
06 1852 0632
Email
maartje.vandenbelt@wur.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole de Wit, PhD
Phone
+31317480310
Email
nicole.dewit@wur.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole de Wit, PhD
Organizational Affiliation
Wageningen Food and Biobased Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Remco Kort, PhD
Organizational Affiliation
VU University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stichting Wageningen Research
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6708 WG
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole de Wit, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32210176
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.
Results Reference
background
PubMed Identifier
32232406
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.
Results Reference
background
PubMed Identifier
34256014
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.
Results Reference
result
PubMed Identifier
24336217
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.
Results Reference
result
Learn more about this trial
Gut Health Enhancement by Eating Favourable Food
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