Study Results
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Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2022-02-01
2022-07-31
Brief Summary
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Hypothesis 2: detailed food intake analysis and continuous monitoring of gut microbiota enables to draw causative interrelationships between food components, bacteria of gut microbiome and health characteristics.
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Detailed Description
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The main goal of this study was to elucidate the patterns between individual dietary fibers and gut microbiota at the personal level. Each person has a unique (individual) intestinal microbiological profile that changes according to lifestyle (diet, environment, physical activity), age and health status. With next generation sequencing methods to map microbial communities and detailed nutritional analysis including blood tests, it is possible to identify the specific effects of specific fiber on a selected (individual) microbiota. TFTAK researchers have long-term experience in microbiota analysis as well as diet design and nutrition analysis, which can be successfully applied in this project.
PRELIMINARY STUDY EVALUATION AND TESTING
1. Complete preliminary study questionnaire
2. Complete orientation to the study and provide voluntary consent to join the study
3. Collection of coded intervention products, sampling supplies, and instructional materials
1-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1\. Record food intake and gastrointestinal function for 7 days 2. Collect health data and provide a 7-day food diary using web-based program Nutridata (tap.nutridata.ee) 3. Provide a stool and blood sample at the laboratory 3-WEEK QUESTIONNAIRE AND
LABORATORY VISITS
1. Record food intake and gastrointestinal symptoms for 7 days
2. Collect health data and provide a 3-day food frequency questionnaire
3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE
ANALYSES
1\. Provide the blood sample at the laboratory in the morning in an overnight fasted state.
DIETARY INTERVENTION
Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs:
1. Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota)
2. Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
3. Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
4. Repeating 3 times periods of 2 and 3. In each dietary fiber period 15 g/day of oat fiber, rye fiber, mix I and mix II of dietary fibers are used as test compounds. Dietary fiber mix I and mix II are inulin, beta-glucan, polydextrose, citrus pectin and psyllium, and beta-glucan, citrus pectin and psyllium, respectively.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Baseline
Collection of baseline data 1 week before intervention
No interventions assigned to this group
Dietary fiber 1
15 g/day oat fiber 3 weeks intervention
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
Dietary fiber 1
Description in the arm description
Wash-out 1
2 weeks
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
No interventions assigned to this group
Dietary fiber 2
15 g/day dietary fiber mix I 3 weeks intervention
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
Dietary fiber 2
Description in the arm description
Wash-out 2
2 weeks
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
No interventions assigned to this group
Dietary fiber 3
15 g/day dietary fiber 3 3 weeks intervention
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
Dietary fiber 3
Description in the arm description
Wash-out 3
2 weeks
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
No interventions assigned to this group
Dietary fiber 4
15 g/day rye fiber 3 weeks intervention
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
Dietary fiber 4
Description in the arm description
Wash-out 4
2 weeks
At the end of period following analyses are collected:
1 week food diary blood sample microbiome sample gut health questionnaire
No interventions assigned to this group
Interventions
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Dietary fiber 1
Description in the arm description
Dietary fiber 2
Description in the arm description
Dietary fiber 3
Description in the arm description
Dietary fiber 4
Description in the arm description
Eligibility Criteria
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Inclusion Criteria
* Normal bowel function
* Omnivorous diet
* Ability to provide a signed written informed consent
* Willing to provide stool and blood specimens over the 22-week study period
Exclusion Criteria
* Medication: statins, blood pressure medications, antidepressants, other prescription medications
* History of bariatric operation, removal of the gallbladder.
* Food allergies, lactose intolerance
* Recent (previous 3 months) use of antibiotics
* Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
* Current pregnancy or breastfeeding
* Volunteers showing previously unrecognized illness will also be excluded
* Individual unable to give informed consent
20 Years
60 Years
ALL
Yes
Sponsors
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Center of Food and Fermentation Technologies
OTHER
Responsible Party
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Kaarel Adamberg
Project manager
Principal Investigators
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Kaarel Adamberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Center of Food and Fermentation Technologies
Locations
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Center of Food and Fermentation Technologies
Tallinn, Harju, Estonia
Countries
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Other Identifiers
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RTKU
Identifier Type: -
Identifier Source: org_study_id
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