Gut Health Enhancement by Eating Favourable Food

Microbial Colonization Clinical Trial

— GEEFomjebuik  

Official title:

Gut Health Enhancement by Eating Favourable Food

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05900609
• Other study ID #: NL83652.028.23
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: March 5, 2024

Study information

• Verified date: September 2023
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: March 5, 2024
• Est. primary completion date: November 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (6)

Lead Sponsor	Collaborator
VU University of Amsterdam	Cidrani, Keep Food Simple, Maag Lever Darm Stichting, Wageningen University and Research, WholeFiber

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. do — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Baseline (week 0)
Other	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	End ramp-up (week 2)
Other	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	End intervention (week 8)
Other	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	End follow-up (5 months)
Primary	Microbiota diversity	Microbioal richness (ASV) using 16s rRNA	Baseline (week 0)
Primary	Microbiota diversity	Microbioal richness (ASV) using 16s rRNA	End ramp-up (week 2)
Primary	Microbiota diversity	Microbioal richness (ASV) using 16s rRNA	End intervention (week 8)
Secondary	Gut microbiota composition	16s rRNA	Baseline (week 0)
Secondary	Gut microbiota composition	16s rRNA	End ramp-up (week 2)
Secondary	Gut microbiota composition	16s rRNA	End intervention (week 8)
Secondary	Carbohydrate Active Enzymes (CAZymes)	Relative abundance of CAZymes using shotgun metagenomic sequencing	Baseline (week 0)
Secondary	Carbohydrate Active Enzymes (CAZymes)	Relative abundance of CAZymes using shotgun metagenomic sequencing	End ramp-up (week 2)
Secondary	Carbohydrate Active Enzymes (CAZymes)	Relative abundance of CAZymes using shotgun metagenomic sequencing	End intervention (week 8)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Dietary intake	Average intake of fiber, fermented foods and macronutrients using the Traqq app	Baseline (week 0)
Secondary	Dietary intake	Average intake of fiber, fermented foods and macronutrients using the Traqq app	End ramp-up (week 2)
Secondary	Dietary intake	Average intake of fiber, fermented foods and macronutrients using the Traqq app	End intervention (week 8)
Secondary	Dietary intake	Average intake of fiber, fermented foods and macronutrients using the Traqq app	End follow-up (5 months)
Secondary	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)
Secondary	Stool frequency	Frequency of bowel movement per day	Daily during intervention (week 0 - week 8)
Secondary	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)
Secondary	Abundance of Prevotella	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	Baseline (week 0)
Secondary	Abundance of Prevotella	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End ramp-up (week 2)
Secondary	Abundance of Prevotella	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End intervention (week 8)
Secondary	Abundance of Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	Baseline (week 0)
Secondary	Abundance of Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End ramp-up (week 2)
Secondary	Abundance of Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End intervention (week 8)
Secondary	Ratio of Prevotella/Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	Baseline (week 0)
Secondary	Ratio of Prevotella/Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End ramp-up (week 2)
Secondary	Ratio of Prevotella/Bacteroides	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End intervention (week 8)
Secondary	Microbial alpha diversity	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	Baseline (week 0)
Secondary	Microbial alpha diversity	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End ramp-up (week 2)
Secondary	Microbial alpha diversity	Based on a faecal smear image, using MicrobeLink tool from HORAIZON (AI, machine learning).	End intervention (week 8)
Secondary	Transit time	Using blue dye method (two blue muffins)	Baseline (week 0)
Secondary	Transit time	Using blue dye method (two blue muffins)	End ramp-up (week 2)
Secondary	Transit time	Using blue dye method (two blue muffins)	End intervention (week 8)
Secondary	Sleep quality	Athens insomnia scale. Score range: 0-28 points. Higher score means worse outcome.	Baseline (week 0)
Secondary	Sleep quality	Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.	End ramp-up (week 2)
Secondary	Sleep quality	Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.	End intervention (week 8)
Secondary	Sleep quality	Athens insomnia scale. Score range: 0-28 points. Higher score indicates worse sleep quality.	End follow-up (5 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)