Trial Outcomes & Findings for Dietary Histone Deacetylase Inhibitors (HDAC) (NCT NCT01543074)
NCT ID: NCT01543074
Last Updated: 2019-04-30
Results Overview
The levels of "Sulforaphane and its metabolites (combined)" in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the "Outcome Measure Data Table".
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.
Results posted on
2019-04-30
Participant Flow
34 Subjects consented for the study at the Linus Pauling Institute clinic, Corvallis, Oregon during the period February, 2013 to November, 2013. However, only 23 who qualified the criteria in the pre-screen blood tests were selected for the study.
Participant milestones
| Measure |
BSE Placebo & Garlic Oil Placebo
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
7
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dietary Histone Deacetylase Inhibitors (HDAC)
Baseline characteristics by cohort
| Measure |
BSE Placebo & Garlic Oil Placebo
n=5 Participants
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
n=7 Participants
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
n=5 Participants
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
n=6 Participants
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
30 years
STANDARD_DEVIATION 14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
23 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.The levels of "Sulforaphane and its metabolites (combined)" in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the "Outcome Measure Data Table".
Outcome measures
| Measure |
BSE Placebo & Garlic Oil Placebo
n=5 Participants
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
n=7 Participants
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
n=5 Participants
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
n=6 Participants
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
|---|---|---|---|---|
|
Cmax of Sulforaphane and Its Metabolites in Blood
|
NA micromoles/L
Standard Deviation NA
below limit of detection
|
NA micromoles/L
Standard Deviation NA
below limit of detection
|
0.92 micromoles/L
Standard Deviation 0.15
|
1.26 micromoles/L
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.The levels of "Sulforaphane and its metabolites (combined)" in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. The time to achieve highest plasma concentration (Tmax) is shown in the "Outcome Measure Data Table".
Outcome measures
| Measure |
BSE Placebo & Garlic Oil Placebo
n=5 Participants
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
n=7 Participants
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
n=5 Participants
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
n=6 Participants
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
|---|---|---|---|---|
|
Tmax of Sulforaphane and Its Metabolites in Blood
|
NA hours
Standard Deviation NA
below limit of detection
|
NA hours
Standard Deviation NA
below limit of detection
|
3 hours
Standard Deviation 0
|
3 hours
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 hPopulation: The data were obtained by analyzing 'representative' patient samples (n=3 per group) using immunoblotting.
Histone acetylation was measured by immunoblotting the levels of acetylated histone H4K12 in the circulating peripheral blood mononuclear cells (PBMCs) of subjects who consumed either placebo, garlic oil, BSE, or BSE+garlic oil. The fold increase in acetylated histone H4K12 in the different groups is shown in the "Outcome Measure Data Table".
Outcome measures
| Measure |
BSE Placebo & Garlic Oil Placebo
n=3 Participants
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
n=3 Participants
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
n=3 Participants
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
n=3 Participants
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
|---|---|---|---|---|
|
Histone Acetylation
|
0.83 Fold change
Standard Deviation 0.15
|
1.03 Fold change
Standard Deviation 0.15
|
1.05 Fold change
Standard Deviation 0.21
|
1.20 Fold change
Standard Deviation 0.26
|
Adverse Events
BSE Placebo & Garlic Oil Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Garlic Oil Plus BSE Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BSE Plus Garlic Oil Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BSE & Garlic Oil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BSE Placebo & Garlic Oil Placebo
n=5 participants at risk
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE \& Garlic Oil: see arm description
|
Garlic Oil Plus BSE Placebo
n=7 participants at risk
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE placebo \& garlic oil placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
BSE Plus Garlic Oil Placebo
n=5 participants at risk
two BSE capsules plus one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE \& Garlic Oil: see arm description
|
BSE & Garlic Oil
n=6 participants at risk
two BSE and one garlic oil capsule per day for seven days
garlic oil plus BSE placebo: see arm description
BSE plus garlic oil placebo: see arm description
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
60.0%
3/5 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
Additional Information
Rod Dashwood
Institute of Biosciences and Technology, Texas A&M Health Science Center, Houston TX
Phone: 7136777806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place