MicrobiomeNCT04114513
Dietary Fibers Effect on the Gut Microbiota Composition
A study testing Maltodextrin, Inulin and Pectin in people with Microbiome and Metabolic Syndrome, run by Atlas Biomed at 1 site in Russia.
Trial summary
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either inulin, pectin, beta-glucan or galactooligosaccharides) will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Metabolic Syndrome, Cardiovascular Risk Factor
- What is being tested?
- Maltodextrin, Inulin and Pectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteRussia
- Study dates
- 25 Nov 2019to 30 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject doesn't have any active complaints
- Subject doesn't have any active or acute diseases at the time of enrollment
- Subject signed informed consent
Who cannot join
- High or very high cardiovascular risk
- Levels of total cholesterol and/or low-density lipoproteins requiring immediate assignment of drug treatment (according to ESC Guidelines for the management of dyslipidaemias, 2019)
- Diabetes mellitus of any type
- HbA1с of 5,7% or higher
- Obesity requiring medical therapy or surgery (according to European Guidelines for Adult Obesity Management, 2019)
- Gastrointestinal diseases in history including ulcerative colitis, Crohn's disease, celiac disease, gallbladder disease (calculous cholecystitis, cholangitis, etc.) not related to functional disorders; liver or pancreas diseases
Show all 19Show fewer
- Irritable bowel syndrome, abdominal pain of any location and etiology
- Pain syndrome of any localization
- Flatulence
- Oncology diseases
- Mental disorders
- Rheumatoid arthritis or other autoimmune diseases
- Acute infectious diseases or exacerbation of any diseases
- Recent (<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention
- Recent (<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives
- Pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment
- Current alcohol/drug abuse (more than 3 points for women and 4 for men according to AUDIT-C questionnaire and/or more than 7 points on the AUDIT questionnaire) or addiction therapy within 12 months prior to screening
- Allergies to any prebiotic or placebo ingredients
- Planned relocation from the home region during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double-blinded, Parallel-group, 5-week Study of the Dietary Fibers Intake (Inulin, Pectin, Beta-glucan, Galactooligosaccharides) Influence on the Gut Microbiota Composition and Cardiovascular Risk Factors
The randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either inulin, pectin, beta-glucan or galactooligosaccharides) will be evaluated. Gut microbiota composition, lipids levels, inflammation markers, microbiome metabolites, changes in quality of life and stool parameters will be assessed in order to predict individual response in participants without serious chronic diseases
Read the detailed description
A randomized double-blinded study will include 270 volunteers without clinical manifestations of chronic diseases. Participants will be randomized into one of five arms daily consuming one of the following: placebo (maltodextrin, 8 g), inulin (8 g), pectin (8 g), beta-glucan (8 g) or oligosaccharides (8 g).
The study will include a 5-day screening period and a 5-weeks intervention period.
During screening stage, a volunteer will complete a questionnaire, and the following measurements will be performed: blood levels of glycated hemoglobin, creatinine, lipids, C-reactive protein, anthropometric measurements, as well as cardiovascular risk will be assessed.
Before and after the intervention blood and stool samples will be collected to conduct the following analyses: an extended lipid spectrum analysis, high-sensitivity C-reactive protein, 16S rRNA gut microbiome sequencing, laboratory stool testing, stool fecal short-chain fatty acids analysis. Anthropometric measures, physical examination will be performed for each volunteer. The following questionnaires will be completed: dietary recall questionnaire, SF-36, the Rome Criteria for the Functional gastrointestinal disorders (functional constipation). The assessed scales will include Bristol stool scale, Hospital Anxiety and Depression Scale (HADS), Hamilton Rating Scale for Depression (HRSD).
- Being tested
- Maltodextrin, Inulin, Pectin, Beta-glucan, Galactooligosaccharides
- Keywords
- Dietary fiber, Gut Microbiota, Cardiovascular risk factors, Lipid metabolism
- Medical subject headings
- Metabolic Syndrome, Inflammation, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaltodextrinDietary supplement
NOVAPRODUKT, white powder 5 weeks intervention
InulinDietary supplement
BENEO-Orafti, white powder 5 weeks intervention
PectinDietary supplement
BANG \& BONSOMER GROUP OY, white powder 5 weeks intervention
Beta-glucanDietary supplement
Tate \& Lyle, white powder 5 weeks intervention
GalactooligosaccharidesDietary supplement
FrieslandCampina, white powder 5 weeks intervention
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. Receives: Dietary Supplement: Maltodextrin |
| Inulin | Experimental | Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. Receives: Dietary Supplement: Inulin |
| Pectin | Experimental | Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. Receives: Dietary Supplement: Pectin |
| Beta-glucan | Experimental | Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. Receives: Dietary Supplement: Beta-glucan |
| Galactooligosaccharides | Experimental | Within first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. Receives: Dietary Supplement: Galactooligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipids levels
LDL, HDL, TC, TG, apoB, Lp(a)
Measured: Change from Baseline Blood lipids levels at 5th week
Change in Gut microbiota composition
Relative abundance of bacterial taxa according to 16S rRNA sequencing data
Measured: Change from Baseline at 5th week
Secondary outcomes (7)
Change in Fecal short-chain fatty acids
Butyrate, propionate and acetate concentrations
Measured: Change from Baseline at 5th week
Change in High sensitive C-reactive protein
Low-grade inflammation assessment
Measured: Change from Baseline at 5th week
Change in Stool consistency
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories.
Measured: Change from Baseline at 5th week
Change in Stool frequency
Rome criteria questionnaire. The Rome IV criteria for the diagnosis of irritable bowel syndrome require that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following : Related to defecation (may be increased or unchanged by defecation)
Measured: Change from Baseline at 5th week
Change in Body Composition
Bioelectrical impedance analysis
Measured: Baseline and 5th week
Change in Quality of Life: SF-36 questionnaire
According to SF-36 questionnaire The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) It is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively
Measured: Change from Baseline at 5th week
Change in Psychological distress
Hospital Anxiety and Depression Scale (HADS) Patients anxiety and depression will be assessed using the HADS : Hospital Anxiety and Depression scale.
Scores of the HADS scale can be defined as:
By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then:
7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology.
By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then:
7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. The minimal score is 0 and the maximal total score is 42.
Measured: Change from Baseline at 5th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start25 Nov 2019
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Why it stopped: COVID-19 lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114513
- Sponsor's protocol ID
- DFI
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blinded, Parallel-group, 5-week Study of the Dietary Fibers Intake (Inulin, Pectin, Beta-glucan, Galactooligosaccharides) Influence on the Gut Microbiota Composition and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04114513
- Acronym / sponsor ID
- DFI
- Keywords
- Dietary fiber, Gut Microbiota, Cardiovascular risk factors, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atlas BiomedIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Oct 2019 (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 randomized double-blinded placebo-controlled multicenter study will be held in parallel groups. During 5 weeks the efficacy of different endpoints as a measure of response to the daily intake of dietary fibers (8 g of either inulin, pectin, beta-glucan or galactooligosaccharides) will be evaluated. Gut microbiota composition, lipids levels, inflammation markers, microbiome metabolites, changes in quality of life and stool parameters will be assessed in order to predict individual response in participants without serious chronic diseases
Detailed description
A randomized double-blinded study will include 270 volunteers without clinical manifestations of chronic diseases. Participants will be randomized into one of five arms daily consuming one of the following: placebo (maltodextrin, 8 g), inulin (8 g), pectin (8 g), beta-glucan (8 g) or oligosaccharides (8 g).
The study will include a 5-day screening period and a 5-weeks intervention period.
During screening stage, a volunteer will complete a questionnaire, and the following measurements will be performed: blood levels of glycated hemoglobin, creatinine, lipids, C-reactive protein, anthropometric measurements, as well as cardiovascular risk will be assessed.
Before and after the intervention blood and stool samples will be collected to conduct the following analyses: an extended lipid spectrum analysis, high-sensitivity C-reactive protein, 16S rRNA gut microbiome sequencing, laboratory stool testing, stool fecal short-chain fatty acids analysis. Anthropometric measures, physical examination will be performed for each volunteer. The following questionnaires will be completed: dietary recall questionnaire, SF-36, the Rome Criteria for the Functional gastrointestinal disorders (functional constipation). The assessed scales will include Bristol stool scale, Hospital Anxiety and Depression Scale (HADS), Hamilton Rating Scale for Depression (HRSD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinWithin first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. |
| Inulin | Experimental | Dietary Supplement: InulinWithin first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. |
| Pectin | Experimental | Dietary Supplement: PectinWithin first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. |
| Beta-glucan | Experimental | Dietary Supplement: Beta-glucanWithin first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. |
| Galactooligosaccharides | Experimental | Dietary Supplement: GalactooligosaccharidesWithin first 6 days, there will be an increase in the fiber dose: 1st and 2nd days - 2g, 3rd and 4th - 4g per day, 5th and 6th - 6g per day. Starting from the 7th and till the 35th day - 8g per day. Placebo will be given in a powder form to be added to 250 ml of water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject doesn't have any active complaints
- Subject doesn't have any active or acute diseases at the time of enrollment
- Subject signed informed consent
Key exclusion criteria (19 listed)
- High or very high cardiovascular risk
- Levels of total cholesterol and/or low-density lipoproteins requiring immediate assignment of drug treatment (according to ESC Guidelines for the management of dyslipidaemias, 2019)
- Diabetes mellitus of any type
- HbA1с of 5,7% or higher
- Obesity requiring medical therapy or surgery (according to European Guidelines for Adult Obesity Management, 2019)
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 |
|---|---|---|
| MaltodextrinNOVAPRODUKT, white powder 5 weeks intervention | Dietary supplement | Maltodextrin |
| InulinBENEO-Orafti, white powder 5 weeks intervention | Dietary supplement | Inulin |
| PectinBANG \& BONSOMER GROUP OY, white powder 5 weeks intervention | Dietary supplement | Pectin |
| Beta-glucanTate \& Lyle, white powder 5 weeks intervention | Dietary supplement | Beta-glucan |
| GalactooligosaccharidesFrieslandCampina, white powder 5 weeks intervention | Dietary supplement | Galactooligosaccharides |
Primary outcome
Blood lipids levels
Time frame: Change from Baseline Blood lipids levels at 5th week
LDL, HDL, TC, TG, apoB, Lp(a)
Change in Gut microbiota composition
Time frame: Change from Baseline at 5th week
Relative abundance of bacterial taxa according to 16S rRNA sequencing data
7 secondary outcomes
Change in Fecal short-chain fatty acids
Time frame: Change from Baseline at 5th week
Change in High sensitive C-reactive protein
Time frame: Change from Baseline at 5th week
Change in Stool consistency
Time frame: Change from Baseline at 5th week
Change in Stool frequency
Time frame: Change from Baseline at 5th week
Change in Body Composition
Time frame: Baseline and 5th week
Change in Quality of Life: SF-36 questionnaire
Time frame: Change from Baseline at 5th week
Change in Psychological distress
Time frame: Change from Baseline at 5th week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin, Inulin and Pectin in people with Microbiome and Metabolic Syndrome, run by Atlas Biomed at 1 site in Russia.
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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 12 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 Russia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Blood lipids levels (time frame: Change from Baseline Blood lipids levels at 5th week). The study lists 2 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 12 Mar 2021.