HealthyNCT05424640
Dietary Fiber and Gut Microbiome Study
A study testing Dietary fiber 1, Dietary fiber 2 and Dietary fiber 3 in people with Healthy, run by Center of Food and Fermentation Technologies at 1 site in Estonia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary fiber 1, Dietary fiber 2 and Dietary fiber 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Feb 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60
- 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
Who cannot join
- 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
- 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
Show all 9Show fewer
- Current pregnancy or breastfeeding
- Volunteers showing previously unrecognized illness will also be excluded
- Individual unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Estonia1 site
Center of Food and Fermentation Technologies
Tallinn, Harju, 12618
About this study
Official title: Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota
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.
Read the detailed description
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
- Complete preliminary study questionnaire
- Complete orientation to the study and provide voluntary consent to join the study
- Collection of coded intervention products, sampling supplies, and instructional materials
1-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- 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
- Record food intake and gastrointestinal symptoms for 7 days
- Collect health data and provide a 3-day food frequency questionnaire
- Provide a stool and blood sample at the laboratory BLOOD SAMPLE
ANALYSES
- 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:
- Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota)
- Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
- Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
- 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
- Healthy
- Being tested
- Dietary fiber 1, Dietary fiber 2, Dietary fiber 3, Dietary fiber 4
- Keywords
- Gut microbiome, food diary, dietary fibers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fiber 1Dietary supplement
Description in the arm description
Dietary fiber 2Dietary supplement
Description in the arm description
Dietary fiber 3Dietary supplement
Description in the arm description
Dietary fiber 4Dietary supplement
Description in the arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Dietary fiber 1 |
| 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 Receives: Dietary Supplement: Dietary fiber 2 |
| 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 | 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 Receives: Dietary Supplement: Dietary fiber 3 |
| 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 Receives: Dietary Supplement: Dietary fiber 4 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the intestinal microbiota
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
Measured: 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)
Measured: 150 days
Evaluation of blood lipid profile
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L).
Measured: 150 days
Evaluation of blood glucose levels
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
Measured: 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).
Measured: 150
Secondary outcomes (3)
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.
Measured: 150 days
Evaluation of the defecation frequency
- Evacuation frequency 7 days before every blood and microbiome sampling.
- Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.
Measured: 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).
Measured: 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Food and Fermentation Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaarel Adamberg, Center of Food and Fermentation Technologies
- Investigators
- Kaarel Adamberg, PhD, Principal investigator, Center of Food and Fermentation Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424640
- Sponsor's protocol ID
- RTKU
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of Specific Dietary Fibers on Dynamics of Individual Gut Microbiota
- ClinicalTrials.gov ID
- NCT05424640
- Acronym / sponsor ID
- RTKU
- Conditions
- Healthy
- Keywords
- Gut microbiome, food diary, dietary fibers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Center of Food and Fermentation TechnologiesUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Complete preliminary study questionnaire
- Complete orientation to the study and provide voluntary consent to join the study
- Collection of coded intervention products, sampling supplies, and instructional materials
1-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- 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
- Record food intake and gastrointestinal symptoms for 7 days
- Collect health data and provide a 3-day food frequency questionnaire
- Provide a stool and blood sample at the laboratory BLOOD SAMPLE
ANALYSES
- 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:
- Baseline mapping (health questionnaire, 1 week food diary before sampling of blood and gut microbiota)
- Dietary fiber 1, 3 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
- Wash-out period, 2 weeks, analyses: health questionnaire, 1 week food diary before sampling of blood and gut microbiota
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Collection of baseline data 1 week before intervention |
| Dietary fiber 1 | Experimental | Dietary Supplement: Dietary fiber 115 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 | Dietary Supplement: Dietary fiber 215 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 | Dietary Supplement: Dietary fiber 315 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 | Dietary Supplement: Dietary fiber 415 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-60
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary fiber 1Description in the arm description | Dietary supplement | Dietary fiber 1 |
| Dietary fiber 2Description in the arm description | Dietary supplement | Dietary fiber 2 |
| Dietary fiber 3Description in the arm description | Dietary supplement | Dietary fiber 3 |
| Dietary fiber 4Description in the arm description | Dietary supplement | Dietary fiber 4 |
Primary outcome
Evaluation of the intestinal microbiota
Time frame: 150 days
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
Evaluation of food consumption data
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)
Evaluation of blood lipid profile
Time frame: 150 days
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol after every intervention and wash-out in plasma (mmol/L).
Evaluation of blood glucose levels
Time frame: 150
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
Evaluation of liver characteristics profile
Time frame: 150
Uric acid, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).
3 secondary outcomes
Evaluation of the stool form
Time frame: 150 days
Evaluation of the defecation frequency
Time frame: 150
Evaluation of the gastrointestinal symptoms
Time frame: 150
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaarel Adamberg, PhD principal investigator
Center of Food and Fermentation Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fiber 1, Dietary fiber 2 and Dietary fiber 3 in people with Healthy, run by Center of Food and Fermentation Technologies at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the intestinal microbiota (time frame: 150 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.