Center of Food and Fermentation Technologies
Tallinn, Harju, 12618, Estonia
NCT Number: NCT05424640
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.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Tallinn, Harju, 12618, Estonia
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
LABORATORY VISITS
ANALYSES
DIETARY INTERVENTION
Study consists of baseline period, four periods of dietary fiber intervention and four periods of wash-outs:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Description in the arm description
Description in the arm description
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Time frame: 150 days
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
Time frame: 150 days
All foods consumed were collected 1 week before the end of every study period using web-based program (tap.nutridata.ee)
Time frame: 150 days
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L).
Time frame: 150
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
Time frame: 150
Uric acid, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).
Time frame: 150 days
Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention.
Time frame: 150
Time frame: 150
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).
Center of Food and Fermentation Technologies
Other
Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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