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Cancer Vaccine

Sulforaphane tablets for Alcoholism

N/A
Recruiting
Led By Aline Zaparte, PhD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in serum interleukin-6 levels after 28 days of intervention.
Awards & highlights

Study Summary

This trial will test if a compound found in broccoli sprouts extract can help improve gut health in individuals with poor nutrition and alcohol use. Chronic alcohol consumption can disrupt the balance of bacteria in the gut,

Who is the study for?
This trial is for adults over 50 who have a poor diet (HEI score below 51) and consume at least 8 alcoholic drinks per week, with an AUDIT-C score greater than 8. It's not suitable for those who don't meet these specific alcohol and dietary criteria.Check my eligibility
What is being tested?
The study is testing the effects of broccoli sprout extract, which contains sulforaphane, against a placebo to see if it can improve gut health by reducing inflammation and oxidative stress in older adults with poor nutrition and regular alcohol use.See study design
What are the potential side effects?
Broccoli sprout extract is considered safe but may cause gas or bloating. Since it's being tested as a supplement, other side effects are not well-known but could include allergic reactions or interactions with medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in serum levels of intestine acid biding proteins after 28 days of intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in serum levels of intestine acid biding proteins after 28 days of intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Inflammation biomarkers
Change on the Leaky gut biomarker

Side effects data

From 2013 Phase 2 trial • 44 Patients • NCT01474993
19%
Vomiting
15%
Abdominal pain
15%
Increased Flatulence
15%
SGPT outside of reference range
15%
Increased aggressions
12%
Increased irritability
12%
Constipation
12%
Diarrhea
12%
Seasonal allergy exacerbation
12%
Fever
12%
Headache
8%
Insomnia
8%
Increased stubbornness
8%
Abnormal WBC count
8%
Seizures
8%
Cough
4%
Hyperactivity
4%
Increased appetite
4%
Abnormal platelet count
4%
TSH outside of reference range
4%
Increased agitation
4%
Crying spells
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sulforaphane-rich Broccoli Sprout Extract

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sulforaphane tabletsExperimental Treatment1 Intervention
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
Group II: Placebo tabletsPlacebo Group1 Intervention
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
115 Previous Clinical Trials
44,023 Total Patients Enrolled
1 Trials studying Alcoholism
68 Patients Enrolled for Alcoholism
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,378 Previous Clinical Trials
4,315,431 Total Patients Enrolled
1 Trials studying Alcoholism
70 Patients Enrolled for Alcoholism
Aline Zaparte, PhDPrincipal InvestigatorPostdoctoral Fellow
~7 spots leftby Aug 2024