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| ID | Type | Description | Link |
|---|---|---|---|
| U24DK132740 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Chronic alcohol consumption leads to perturbations in gut microbiome balance (dysbiosis) and disruption of gut barrier integrity. As a result, bacteria, toxins, and metabolites can enter the blood stream and reach distant organs, triggering inflammation and oxidative stress. Through this mechanism gut leak is closely related to the onset of metabolic diseases, such as nonalcoholic fatty liver disease (NAFLD) and diabetes.
Despite the prominent role of diet and alcohol in the pathogenesis of metabolic diseases, there is a lack of treatments to mitigate their effects in triggering systemic inflammation and oxidative stress. Novel treatments using generally recognized as safe (GRAS) compounds focused on restoring the intestinal barrier to mitigate metabolite endotoxemia are sorely needed. This project will test the potential of broccoli sprouts extract (BSE) as a GRAS treatment to minimize the combined effect of poor nutrition and alcohol on the gut. Broccoli sprouts are rich in sulforaphane, a bioactive compound derived from the glucosinolate glucoraphanin with anti-inflammatory and antioxidant proprieties. BSE supplementation has been used in preclinical and clinical studies as a health- promoting food, showing significant positive changes in the gut microbiota composition, protection against colitis, cardiometabolic improvement, and lower inflammation. We believe that BSE is a viable alternative therapeutic approach for patients who are resistant to lifestyle changes such as healthy eating and reducing alcohol use. Our purpose is to test BSE supplementation in human subjects with poor nutrition compounded by alcohol use, specifically in older adults who we believe will receive greater benefit from this approach. At the completion of the proposed study, we expect to have determined that treatments using generally recognized as safe (GRAS) compounds can be useful to restore the gut barrier integrity, and as consequence of reduced gut leak we expect to observe lower inflammation and oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane tablets | Experimental | People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days. |
|
| Placebo tablets | Placebo Comparator | People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generally Recognized as Safe - Sulforaphane | Dietary Supplement | Participants will be asked to maintain the same food ingestion habits as before the study and take 2 tablets of Sulforaphane a day with a meal for 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Leak | Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein. | Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Inflammation | Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1β) are proteins in the blood that help control the body's immune and inflammatory responses. They are released when the body is reacting to stress, infection, or injury. Higher levels of these markers generally indicate increased inflammation in the body and are commonly used to assess overall immune system activity. | After 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress Markers - Malondialdehyde (MDA) | Oxidative stress occurs when there is an imbalance between harmful molecules (free radicals) and the body's ability to neutralize them. Malondialdehyde (MDA) is a byproduct of cell damage caused by oxidative stress, so higher levels indicate increased damage. | After 28 days of treatment |
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria:
• Any health issue that, the study investigator's judgement, confers excess risk for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Aline Zaparte, PhD | Postdoctoral Fellow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
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No participants were excluded before assignment. 40 participants initiated the study but only 38 completed the study.
Participants were recruited through the distribution of flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Compound Group | Participants of the active group received the active compound (2 capsules of Sulforaphane total 475mg) during 4 weeks. |
| FG001 | Placebo Group | Participants of this group received placebo capsules, containing only the capsules excipients during 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane Tablets | People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days. |
| BG001 | Placebo Tablets | People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gut Leak | Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein. | Intestinal fatty acid-binding protein (iFABP) and lipopolysaccharide-binding protein (LBP) are blood markers used to assess gut health and inflammation. iFABP is released into the bloodstream when cells lining the intestine are damaged, so higher levels may indicate injury to the gut lining. LBP is a protein that binds to bacterial components from the gut (called lipopolysaccharides), and higher levels may reflect increased exposure of the body to these bacterial products. | Posted | Mean | Standard Deviation | ng/mL | Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days. |
|
Weekly follow-ups up from enrollment up to 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulforaphane Tablets | People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aline Zaparte | LSUHSC | 504-568-3431 | azapar@lsuhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2024 | Mar 19, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Labels of the product will be replaced with "Tablets A" and "Tablets B" labels.
|
| Placebo | Dietary Supplement | Participants will be asked to maintain the same food ingestion habits as before the study and take 2 tablets of placebo a day with a meal for 28 days. |
|
|
| Total Antioxidant Capacity (TAC) |
Total Antioxidant Capacity (TAC) reflects the combined ability of all antioxidants in the blood (such as vitamins, proteins, and enzymes) to neutralize these harmful molecules, providing an overall measure of the body's defense system rather than a single antioxidant. |
| After 28 days of treatment |
| GSH/GSSG Ratio | GSH (reduced glutathione) is an active antioxidant that helps protect cells from damage, while GSSG (oxidized glutathione) is the form it becomes after neutralizing harmful molecules. The GSH/GSSG ratio shows the balance between these two forms, with lower ratios generally indicating higher oxidative stress and reduced antioxidant protection. | After 28 days of treatment |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Demographics | Count of Participants | Participants |
|
| Intestine Acid Fatty Biding Protein | Biomarkers of enterocyte injury | Mean | Standard Deviation | μg/mL |
|
| LPS Biding Protein | Indirect biomarker of material translocation - endotoxemia | Mean | Standard Deviation | µg/mL |
|
| Malondialdehyde (MDA) | Biomarker of Lipid Peroxidation - Oxidative Stress | Mean | Standard Deviation | µM/mL |
|
| Total Antioxidant Capacity (TAC) | Total Antioxidant Capacity (TAC) reflects the combined ability of all antioxidants in the blood to neutralize these harmful molecules. | Mean | Standard Deviation | µM |
|
| GSH/GSSG redox ratio | GSH (reduced glutathione) is an active antioxidant that helps protect cells from damage, while GSSG (oxidized glutathione) is the form it becomes after neutralizing harmful molecules. The GSH/GSSG ratio shows the balance between these two forms, with lower ratios generally indicating higher oxidative stress and reduced antioxidant protection. | Mean | Standard Deviation | Ratio |
|
| Interleukin-6 | IL-6 is a mediator of the immediate "acute phase response" to infection or injury but also acts as a driver of persistent, long-lasting chronic inflammation. | Mean | Standard Deviation | pg/mL |
|
| Interleukin-1 beta (IL-1β) | IL-1β is a potent pro-inflammatory cytokine that acts as a key mediator in both acute and chronic inflammation. It initiates rapid, acute responses to infection or injury, but also drives sustained, chronic inflammation. | Mean | Standard Deviation | pg/mL |
|
| OG001 | Placebo Tablets | People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. |
|
|
| Secondary | Biomarkers of Inflammation | Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1β) are proteins in the blood that help control the body's immune and inflammatory responses. They are released when the body is reacting to stress, infection, or injury. Higher levels of these markers generally indicate increased inflammation in the body and are commonly used to assess overall immune system activity. | Posted | Mean | Standard Deviation | pg/mL | After 28 days of treatment |
|
|
|
| Other Pre-specified | Oxidative Stress Markers - Malondialdehyde (MDA) | Oxidative stress occurs when there is an imbalance between harmful molecules (free radicals) and the body's ability to neutralize them. Malondialdehyde (MDA) is a byproduct of cell damage caused by oxidative stress, so higher levels indicate increased damage. | Posted | Mean | Standard Deviation | μg/mL | After 28 days of treatment |
|
|
|
| Other Pre-specified | Total Antioxidant Capacity (TAC) | Total Antioxidant Capacity (TAC) reflects the combined ability of all antioxidants in the blood (such as vitamins, proteins, and enzymes) to neutralize these harmful molecules, providing an overall measure of the body's defense system rather than a single antioxidant. | Posted | Mean | Standard Deviation | mM | After 28 days of treatment |
|
|
|
| Other Pre-specified | GSH/GSSG Ratio | GSH (reduced glutathione) is an active antioxidant that helps protect cells from damage, while GSSG (oxidized glutathione) is the form it becomes after neutralizing harmful molecules. The GSH/GSSG ratio shows the balance between these two forms, with lower ratios generally indicating higher oxidative stress and reduced antioxidant protection. | Posted | Mean | Standard Deviation | Ratio | After 28 days of treatment |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo Tablets | People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |