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Dietary Histone Deacetylase Inhibitors (HDAC)

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ClinicalTrials.gov Identifier: NCT01543074
Recruitment Status : Terminated (Poor recruitment)
First Posted : March 2, 2012
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Roderick Dashwood, Texas A&M University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Histone Deacetylase (HDAC) Activity
Interventions Dietary Supplement: BSE placebo
Dietary Supplement: Garlic oil
Drug: BSE
Dietary Supplement: Garlic Oil Placebo
Enrollment 23
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 5 7 5 6
Completed 5 7 5 6
Not Completed 0 0 0 0
Arm/Group Title BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 5 7 5 6 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 7 participants 5 participants 6 participants 23 participants
27.8  (14.1) 29.9  (10.1) 30.8  (17.2) 33.7  (18.1) 30  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 5 participants 6 participants 23 participants
Female
4
  80.0%
3
  42.9%
4
  80.0%
1
  16.7%
12
  52.2%
Male
1
  20.0%
4
  57.1%
1
  20.0%
5
  83.3%
11
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 7 participants 5 participants 6 participants 23 participants
5 7 5 6 23
1.Primary Outcome
Title Cmax of Sulforaphane and Its Metabolites in Blood
Hide Description 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".
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 5 7 5 6
Mean (Standard Deviation)
Unit of Measure: micromoles/L
NA [1]   (NA) NA [1]   (NA) 0.92  (0.15) 1.26  (0.17)
[1]
below limit of detection
2.Primary Outcome
Title Tmax of Sulforaphane and Its Metabolites in Blood
Hide Description 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".
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Hide Arm/Group Description:

Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days

BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day

Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day

one garlic oil capsule plus 2 BSE placebo capsules per day for seven days

BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day

Garlic oil: 1 pill = 30 mg garlic oil/day

two BSE capsules plus one garlic oil placebo capsule per day for seven days

BSE: 2 pills = 200 micromoles of Sulforaphane/day

Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day

two BSE and one garlic oil capsule per day for seven days

Garlic oil: 1 pill = 30 mg garlic oil/day

BSE: 2 pills = 200 micromoles of Sulforaphane/day

Overall Number of Participants Analyzed 5 7 5 6
Mean (Standard Deviation)
Unit of Measure: hours
NA [1]   (NA) NA [1]   (NA) 3  (0) 3  (0)
[1]
below limit of detection
3.Secondary Outcome
Title Histone Acetylation
Hide Description Change in histone acetylation
Time Frame 21 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/7 (0.00%)      0/5 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BSE Placebo & Garlic Oil Placebo Garlic Oil Plus BSE Placebo BSE Plus Garlic Oil Placebo BSE & Garlic Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      1/7 (14.29%)      3/5 (60.00%)      1/6 (16.67%)    
Gastrointestinal disorders         
Abdominal discomfort   0/5 (0.00%)  0 1/7 (14.29%)  1 3/5 (60.00%)  3 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
Early termination (23/80) due to small numbers of subjects recruited.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rod Dashwood
Organization: Institute of Biosciences and Technology, Texas A&M Health Science Center, Houston TX
Phone: 7136777806
Responsible Party: Roderick Dashwood, Texas A&M University
ClinicalTrials.gov Identifier: NCT01543074     History of Changes
Other Study ID Numbers: CA122959
First Submitted: February 17, 2012
First Posted: March 2, 2012
Results First Submitted: June 1, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015