Louisiana Health Sciences Center
New Orleans, Louisiana, 70112, United States
NCT Number: NCT05902754
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.
Looking for future studies?
Notify Me50 year–80 year
All sexes
Interventional
Not applicable
New Orleans, Louisiana, 70112, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional exclusion criteria:
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.
Other names: Avmacol
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.
Other names: Inactive tablets
Time frame: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
Time frame: After 28 days of treatment
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.
Time frame: After 28 days of treatment
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.
Time frame: After 28 days of treatment
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.
Time frame: After 28 days of treatment
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.
Louisiana State University Health Sciences Center in New Orleans
Other
Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality
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