Dietary Histone Deacetylase Inhibitors (HDAC)

This study has been terminated.
(Poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Roderick Dashwood, Texas A&M University
ClinicalTrials.gov Identifier:
NCT01543074
First received: February 17, 2012
Last updated: August 10, 2015
Last verified: August 2015
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    BSE Placebo & Garlic Oil Placebo     Garlic Oil Plus BSE Placebo     BSE Plus Garlic Oil Placebo     BSE & Garlic Oil  
STARTED     5     7     5     6  
COMPLETED     5     7     5     6  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    BSE Placebo & Garlic Oil Placebo     Garlic Oil Plus BSE Placebo     BSE Plus Garlic Oil Placebo     BSE & Garlic Oil     Total  
Number of Participants  
[units: participants]
  5     7     5     6     23  
Age  
[units: years]
Mean (Standard Deviation)
  27.8  (14.1)     29.9  (10.1)     30.8  (17.2)     33.7  (18.1)     30  (14)  
Gender  
[units: participants]
         
Female     4     3     4     1     12  
Male     1     4     1     5     11  
Region of Enrollment  
[units: participants]
         
United States     5     7     5     6     23  



  Outcome Measures
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1.  Primary:   Cmax of Sulforaphane and Its Metabolites in Blood   [ 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. ]

2.  Primary:   Tmax of Sulforaphane and Its Metabolites in Blood   [ 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. ]

3.  Secondary:   Histone Acetylation   [ Time Frame: 21 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination (23/80) due to small numbers of subjects recruited.


  More Information
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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
e-mail: rdashwood@ibt.tamhsc.edu



Responsible Party: Roderick Dashwood, Texas A&M University
ClinicalTrials.gov Identifier: NCT01543074     History of Changes
Other Study ID Numbers: CA122959
Study First Received: February 17, 2012
Results First Received: June 1, 2015
Last Updated: August 10, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration