ObesityPhase 1NCT02656056
Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
A Phase 1 study testing Food: (Q-Can Plus fermented soybean beverage) in people with Obesity, run by Yale University at 1 site in United States.
Trial summary
The consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Food: (Q-Can Plus fermented soybean beverage)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
- Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)
Who cannot join
- Allergy to soy or soy derivatives.
- Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
- History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding.
- Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment).
- Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
- Patients will be excluded if using medications which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin.
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- Alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use.
- Major changes in dietary habits in past six months.
- Pregnancy or intent to get pregnant during study period
- Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.
Read the detailed description
The study will start with a detailed testing of the microorganisms present in the QC fermented soy liquid, using deep sequencing. Subsequently, the researchers will determine the effect of the QC fermented soy product on the microbiome and inflammation in lean and obese individuals, as obese individuals are known to have dysbiosis. The work on inflammatory changes will be supplemented by studies to investigate the cellular and molecular mechanistic pathways responsible for the biological action of QC fermented soy liquid.
- Conditions
- Obesity
- Being tested
- Food: (Q-Can Plus fermented soybean beverage)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food: (Q-Can Plus fermented soybean beverage)Other
Fermented soybean beverage. Dose is 8 oz, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Lean Adults | Experimental | Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily. Receives: Other: Food: (Q-Can Plus fermented soybean beverage) |
| Obese Adults | Experimental | Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily. Receives: Other: Food: (Q-Can Plus fermented soybean beverage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome species proportion- Oral
Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.
Measured: baseline to week 12
Change in microbiome species proportion- Intestinal
Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.
Measured: baseline to week 12
Secondary outcomes (6)
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β
This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of Pro-Il-1β. Up-regulation of pro-cytokines will be performed by quantitative PCR.
Measured: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α
This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of Pro-TNF-α. Up-regulation of pro-cytokines will be performed by quantitative PCR.
Measured: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage
This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce caspase-1 cleavage.
Measured: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β
This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of IL-1β production. Detection of cytokines will be by conventional ELISA.
Measured: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α
This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of TNF-α production. Detection of cytokines will be by conventional ELISA.
Measured: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells
Damage associated molecular patterns (DAMPs) will be assayed.
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- BESO Biological Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Eugene Shapiro, MD, Principal investigator, Yale UniversityWajahat Mehal, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656056
- Sponsor's protocol ID
- 1507016139
- Status last verified
- May 2018
- First submitted
- 6 Jan 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dioletis E, Paiva RS, Kaffe E, Secor ER, Weiss TR, Fields MR, Ouyang X, Ali A. The fermented soy beverage Q-CAN(R) plus induces beneficial changes in the oral and intestinal microbiome. BMC Nutr. 2021 Mar 4;7(1):6. doi: 10.1186/s40795-021-00408-4.
PubMed 33658080
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
- ClinicalTrials.gov ID
- NCT02656056
- Acronym / sponsor ID
- 1507016139
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- BESO Biological Research, Inc.
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- 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 consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC") fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.
Detailed description
The study will start with a detailed testing of the microorganisms present in the QC fermented soy liquid, using deep sequencing. Subsequently, the researchers will determine the effect of the QC fermented soy product on the microbiome and inflammation in lean and obese individuals, as obese individuals are known to have dysbiosis. The work on inflammatory changes will be supplemented by studies to investigate the cellular and molecular mechanistic pathways responsible for the biological action of QC fermented soy liquid.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean Adults | Experimental | Other: Food: (Q-Can Plus fermented soybean beverage)Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily. |
| Obese Adults | Experimental | Other: Food: (Q-Can Plus fermented soybean beverage)Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10)
- Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10)
Key exclusion criteria (10 listed)
- Allergy to soy or soy derivatives.
- Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair).
- History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding.
- Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment).
- Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function.
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 |
|---|---|---|
| Food: (Q-Can Plus fermented soybean beverage)Fermented soybean beverage. Dose is 8 oz, twice daily. | Other | Lean Adults, Obese Adults |
Primary outcome
Change in microbiome species proportion- Oral
Time frame: baseline to week 12
Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.
Change in microbiome species proportion- Intestinal
Time frame: baseline to week 12
Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes.
6 secondary outcomes
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β
Time frame: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α
Time frame: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage
Time frame: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β
Time frame: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α
Time frame: baseline to week 12
Change in activation of the inflammasome machinery in peripheral blood cells
Time frame: baseline to week 12
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 11 May 2018.
- Derived from this study: PubMed 33658080Dioletis E, Paiva RS, Kaffe E, Secor ER, Weiss TR, Fields MR, Ouyang X, Ali A. The fermented soy beverage Q-CAN(R) plus induces beneficial changes in the oral and intestinal microbiome. BMC Nutr. 2021 Mar 4;7(1):6. doi: 10.1186/s40795-021-00408-4.
- Individual participant dataSharing planned: Undecided
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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.
Eugene Shapiro, MD principal investigator
Yale University
Wajahat Mehal, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Food: (Q-Can Plus fermented soybean beverage) in people with Obesity, run by Yale University at 1 site in United States.
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 2 inclusion and 10 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 11 May 2018. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in microbiome species proportion- Oral (time frame: baseline to week 12). 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?
On the ClinicalTrials.gov record for NCT02656056, which also lists 1 linked publication.
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 11 May 2018.