HealthyNCT04811157
The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
A study testing Test product 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 dietary fibers on the gut microbiota and use yoghurt as the carrier. Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Apr 2020to 31 Aug 2020
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-55
- Normal bowel function
- Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
- Ability to provide a signed written informed consent
- Willing to provide stool and blood specimens 2 times over the 2-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
The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.
Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.
Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.
Read the detailed description
The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.
PRE-STUDY EVALUATION AND TESTING
- Complete pre-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 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal symptoms for 3 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
- Daily intake of a test or control product for two weeks.
- Conditions
- Healthy
- Being tested
- Test product, Control product
- Keywords
- microbiome, bifidobacteria, fermented dairy product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productDietary supplement
200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
Control productDietary supplement
200 g/day of unsweetened yogurt
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Healthy adults consuming test product Receives: Dietary Supplement: Test product |
| Control group | Placebo comparator | Healthy adults consuming control product Receives: Dietary Supplement: Control product |
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 rRNA sequencing pre- and post-dietary intervention.
Measured: 14 days
Evaluation of blood lipid profile
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
Measured: 14 days
Evaluation of blood glucose levels
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
Measured: 14 days
Secondary outcomes (5)
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: 14 days
Evaluation of the defecation frequency
- Evacuation frequency during 3 days pre- and post-dietary intervention.
- Evacuation frequency (number of bowel movements per week) pre- and post-dietary intervention.
Measured: 14 days
Evaluation of the defecation timing
Evacuation timing 3 days before sampling pre- and post-dietary intervention.
Measured: 14 days
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: 14 days
Evaluation of the blood vitamin D status
25-OH vitamin D pre- and post-dietary intervention in plasma.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Apr 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Food and Fermentation Technologies
- Sponsor type
- University, hospital or other
- Collaborators
- SYNLAB Eesti OÜ, Tallinn, Estonia, AS FARMI Piimatööstus, Jõhvi, Estonia
- Responsible party
- Principal investigator, Madis Jaagura, Center of Food and Fermentation Technologies
- Investigators
- Madis Jaagura, MSc, Principal investigator, TFTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811157
- Sponsor's protocol ID
- 2014-2020.4.02.19-0198
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
- ClinicalTrials.gov ID
- NCT04811157
- Acronym / sponsor ID
- 2014-2020.4.02.19-0198
- Conditions
- Healthy
- Keywords
- microbiome, bifidobacteria, fermented dairy product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Center of Food and Fermentation TechnologiesUniversity, hospital or other
- Collaborators
- SYNLAB Eesti OÜ, Tallinn, Estonia, AS FARMI Piimatööstus, Jõhvi, Estonia
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 23 Mar 2021 (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 dietary fibers on the gut microbiota and use yoghurt as the carrier.
Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.
Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.
Detailed description
The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.
PRE-STUDY EVALUATION AND TESTING
- Complete pre-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 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal symptoms for 3 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
- Daily intake of a test or control product for two weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Dietary Supplement: Test productHealthy adults consuming test product |
| Control group | Placebo comparator | Dietary Supplement: Control productHealthy adults consuming control product |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25-55
- Normal bowel function
- Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
- Ability to provide a signed written informed consent
- Willing to provide stool and blood specimens 2 times over the 2-week study period
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
- 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
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 |
|---|---|---|
| Test product200 g/day of unsweetened yogurt supplemented with a dietary fiber blend | Dietary supplement | Test group |
| Control product200 g/day of unsweetened yogurt | Dietary supplement | Control group |
Primary outcome
Evaluation of the intestinal microbiota
Time frame: 14 days
Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
Evaluation of blood lipid profile
Time frame: 14 days
Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
Evaluation of blood glucose levels
Time frame: 14 days
Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
5 secondary outcomes
Evaluation of the stool form
Time frame: 14 days
Evaluation of the defecation frequency
Time frame: 14 days
Evaluation of the defecation timing
Time frame: 14 days
Evaluation of the gastrointestinal symptoms
Time frame: 14 days
Evaluation of the blood vitamin D status
Time frame: 14 days
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 23 Mar 2021.
- Individual participant dataSharing planned: Undecided. 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.
Madis Jaagura, MSc principal investigator
TFTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product 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 23 Mar 2021. 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. Some participants in this study may receive a placebo. 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: 14 days). The study lists 3 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 23 Mar 2021.