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| Name | Class |
|---|---|
| BESO Biological Research, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lean Adults | Experimental | Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily. |
|
| Obese Adults | Experimental | Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food: (Q-Can Plus fermented soybean beverage) | Other | Fermented soybean beverage. Dose is 8 oz, twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Dietary Recall | ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire | 2 weeks prior to baseline (at baseline) |
| 24-hour Dietary Recall |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Shapiro, MD | Yale University | Principal Investigator |
| Wajahat Mehal, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33658080 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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. |
| 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. | 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. | 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. | baseline to week 12 |
| Change in activation of the inflammasome machinery in peripheral blood cells | Damage associated molecular patterns (DAMPs) will be assayed. | baseline to week 12 |
ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire
| baseline |
| 24-hour Dietary Recall | ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire | 4 weeks |
| 24-hour Dietary Recall | ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |