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The purpose of this dietary intervention is to study the effects of several dietary fibers on the gut microbiota at the personal level. Hypothesis 1: Intake of specific dietary fibers improves the blood lipid profile depending on the personal microbiota of the participants.
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.
The study design is a cross-over, pre-post intervention trial. All participants are enrolled into all study periods. Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs.
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-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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | No Intervention | Collection of baseline data 1 week before intervention | |
| Dietary fiber 1 | Experimental | 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 |
|
| Wash-out 1 | No Intervention | 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire | |
| Dietary fiber 2 | Experimental | 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 |
|
| Wash-out 2 | No Intervention | 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire | |
| Dietary fiber 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary fiber 1 | Dietary Supplement | Description in the arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the intestinal microbiota | Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention. | 150 days |
| Evaluation of food consumption data | All foods consumed were collected 1 week before the end of every study period using web-based program (tap.nutridata.ee) | 150 days |
| Evaluation of blood lipid profile | Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L). | 150 days |
| Evaluation of blood glucose levels | Fasting glucose pre- and post-dietary intervention in plasma (mmol/L). | 150 |
| Evaluation of liver characteristics profile | Uric acid, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L). | 150 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the stool form | Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention. | 150 days |
| Evaluation of the defecation frequency |
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Inclusion Criteria:
Age 20-60
Exclusion Criteria:
Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Kaarel Adamberg, PhD | Center of Food and Fermentation Technologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Food and Fermentation Technologies | Tallinn | Harju | 12618 | Estonia |
Anonymized participant data could be made available for subsequent analysis in the mentioned institution (TFTAK). Data made public will include only aggregates or summaries of the collected data.
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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 |
|
| Wash-out 3 | No Intervention | 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire |
| Dietary fiber 4 | Experimental | 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 |
|
| Wash-out 4 | No Intervention | 2 weeks At the end of period following analyses are collected: 1 week food diary blood sample microbiome sample gut health questionnaire |
| Dietary fiber 2 |
| Dietary Supplement |
Description in the arm description |
|
| Dietary fiber 3 | Dietary Supplement | Description in the arm description |
|
| Dietary fiber 4 | Dietary Supplement | Description in the arm description |
|
| 150 |
| Evaluation of the gastrointestinal symptoms | Frequency and severity of the gastrointestinal symptoms (Constipation, Diarrhea, Bloating, Flatulence, Cramps, Stomach pain). Scale of frequency: Never, Less than 10 times a year, Once a month, Once a week, Every day. Scale of severity: I do not have any gastrointestinal symptoms, Mild (does not disturb), Moderate, Strong (disturbs considerably). | 150 |