Trial Outcomes & Findings for Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder (NCT NCT05902754)
NCT ID: NCT05902754
Last Updated: 2026-04-28
Results Overview
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
COMPLETED
NA
40 participants
Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.
2026-04-28
Participant Flow
Participants were recruited through the distribution of flyers.
No participants were excluded before assignment. 40 participants initiated the study but only 38 completed the study.
Participant milestones
| Measure |
Placebo Group
Participants of this group received placebo capsules, containing only the capsules excipients during 4 weeks.
|
Active Compound Group
Participants of the active group received the active compound (2 capsules of Sulforaphane total 475mg) during 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo Group
Participants of this group received placebo capsules, containing only the capsules excipients during 4 weeks.
|
Active Compound Group
Participants of the active group received the active compound (2 capsules of Sulforaphane total 475mg) during 4 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
LPS Biding Protein
|
29.45 µg/mL
STANDARD_DEVIATION 5.59 • n=9 Participants
|
27.33 µg/mL
STANDARD_DEVIATION 8.28 • n=24 Participants
|
28.39 µg/mL
STANDARD_DEVIATION 7.05 • n=23 Participants
|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 7.2 • n=9 Participants
|
62.3 Years
STANDARD_DEVIATION 6.2 • n=24 Participants
|
60.23 Years
STANDARD_DEVIATION 6.05 • n=23 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
7 Participants
n=24 Participants
|
15 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
5 Participants
n=24 Participants
|
9 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
14 Participants
n=24 Participants
|
28 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Intestine Acid Fatty Biding Protein
|
2.66 μg/mL
STANDARD_DEVIATION 1.46 • n=9 Participants
|
2.86 μg/mL
STANDARD_DEVIATION 1.23 • n=24 Participants
|
2.76 μg/mL
STANDARD_DEVIATION 1.35 • n=23 Participants
|
|
Malondialdehyde (MDA)
|
0.200 µM/mL
STANDARD_DEVIATION 0.120 • n=9 Participants
|
0.183 µM/mL
STANDARD_DEVIATION 0.130 • n=24 Participants
|
0.191 µM/mL
STANDARD_DEVIATION 0.125 • n=23 Participants
|
|
Total Antioxidant Capacity (TAC)
|
75.92 µM
STANDARD_DEVIATION 9.79 • n=9 Participants
|
80.05 µM
STANDARD_DEVIATION 16.79 • n=24 Participants
|
78.02 µM
STANDARD_DEVIATION 13.80 • n=23 Participants
|
|
GSH/GSSG redox ratio
|
0.54 Ratio
STANDARD_DEVIATION 0.20 • n=9 Participants
|
0.57 Ratio
STANDARD_DEVIATION 0.16 • n=24 Participants
|
0.56 Ratio
STANDARD_DEVIATION 0.18 • n=23 Participants
|
|
Interleukin-6
|
4.61 pg/mL
STANDARD_DEVIATION 2.90 • n=9 Participants
|
4.08 pg/mL
STANDARD_DEVIATION 2.80 • n=24 Participants
|
4.34 pg/mL
STANDARD_DEVIATION 2.80 • n=23 Participants
|
|
Interleukin-1 beta (IL-1β)
|
6.97 pg/mL
STANDARD_DEVIATION 0.77 • n=9 Participants
|
7.09 pg/mL
STANDARD_DEVIATION 0.63 • n=24 Participants
|
7.03 pg/mL
STANDARD_DEVIATION 0.70 • n=23 Participants
|
PRIMARY outcome
Timeframe: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.Population: 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.
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
Outcome measures
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
|---|---|---|
|
Gut Leak
Intestinal Fatty Acid Biding Protein - iFABP
|
2.60 ng/mL
Standard Deviation 1.05
|
3.23 ng/mL
Standard Deviation 1.80
|
|
Gut Leak
LPS Biding Protein
|
26.75 ng/mL
Standard Deviation 6.33
|
28.57 ng/mL
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: After 28 days of treatmentInterleukin-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.
Outcome measures
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
|---|---|---|
|
Biomarkers of Inflammation
Interleukin-6 (IL-6)
|
3.40 pg/mL
Standard Deviation 1.79
|
3.68 pg/mL
Standard Deviation 2.78
|
|
Biomarkers of Inflammation
Interleukin-1 beta (IL-1β)
|
6.94 pg/mL
Standard Deviation 0.62
|
6.95 pg/mL
Standard Deviation 0.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 28 days of treatmentOxidative 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.
Outcome measures
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
|---|---|---|
|
Oxidative Stress Markers - Malondialdehyde (MDA)
|
0.245 μg/mL
Standard Deviation 0.165
|
0.209 μg/mL
Standard Deviation 0.156
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 28 days of treatmentTotal 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.
Outcome measures
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
|---|---|---|
|
Total Antioxidant Capacity (TAC)
|
85.28 mM
Standard Deviation 17.4
|
82.80 mM
Standard Deviation 12.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 28 days of treatmentGSH (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.
Outcome measures
| Measure |
Sulforaphane Tablets
n=19 Participants
People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
|
Placebo Tablets
n=19 Participants
People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
|
|---|---|---|
|
GSH/GSSG Ratio
|
0.69 Ratio
Standard Deviation 0.21
|
0.56 Ratio
Standard Deviation 0.15
|
Adverse Events
Sulforaphane Tablets
Placebo Tablets
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place