Dietary Histone Deacetylase Inhibitors (HDAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Oregon State University
Sponsor:
Information provided by (Responsible Party):
Oregon State University
ClinicalTrials.gov Identifier:
NCT01543074
First received: February 17, 2012
Last updated: June 18, 2013
Last verified: June 2013

February 17, 2012
June 18, 2013
March 2013
April 2014   (final data collection date for primary outcome measure)
HDAC activity [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Change in HDAC activity.
Same as current
Complete list of historical versions of study NCT01543074 on ClinicalTrials.gov Archive Site
Histone acetylation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Change in histone acetylation
Histone acetylation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Change in histone actylation
Not Provided
Not Provided
 
Dietary Histone Deacetylase Inhibitors (HDAC)
Dietary HDAC Inhibitors

This pilot, three-week study will help scientists understand more about how the foods people eat can modify histone deacetylases, enzymes the body produces naturally. Broccoli sprout extract (BSE) and garlic oil are thought to modify these enzymes. The purpose of this study is to see if taking broccoli sprout extract alone, garlic oil alone, or broccoli sprout extract and garlic oil together, can decrease the action of histone deacetylase (HDAC) and turn on genes in white blood cells. There will be 80 people in this study.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
HDAC Activity
  • Drug: BSE placebo & garlic oil placebo
    see arm description
  • Dietary Supplement: garlic oil plus BSE placebo
    see arm description
  • Dietary Supplement: BSE plus garlic oil placebo
    see arm description
  • Dietary Supplement: BSE & Garlic Oil
    see arm description
  • Placebo Comparator: BSE placebo & garlic oil placebo
    Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
    Interventions:
    • Drug: BSE placebo & garlic oil placebo
    • Dietary Supplement: BSE & Garlic Oil
  • Active Comparator: garlic oil plus BSE placebo
    one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
    Interventions:
    • Drug: BSE placebo & garlic oil placebo
    • Dietary Supplement: BSE plus garlic oil placebo
  • Active Comparator: BSE plus garlic oil placebo
    two BSE capsules plus one garlic oil placebo capsule per day for seven days
    Interventions:
    • Dietary Supplement: garlic oil plus BSE placebo
    • Dietary Supplement: BSE & Garlic Oil
  • Active Comparator: BSE & Garlic Oil
    two BSE and one garlic oil capsule per day for seven days
    Interventions:
    • Dietary Supplement: garlic oil plus BSE placebo
    • Dietary Supplement: BSE plus garlic oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  • age: 20 and older
  • body mass index 19-30 kg/sq m
  • willingness to maintain normal exercise and activity patterns
  • willingness to avoid cruciferous vegetables and garlic and related foods (onion etc.) 1 week before and 2 weeks during the trial for a total of 3 weeks

Exclusion criteria:

  • tobacco use within the past three months
  • engaging in aerobic activity more than 6 hours per week
  • being vegetarian or having other restrictive dietary requirements
  • consuming >3 alcoholic beverages/day or >10 per week
  • having history of diabetes or uremia or other known metabolic disease
  • participating in another dietary study within the past three months
  • for women, being pregnant or breastfeeding
  • gastrointestinal diseases that could increase gut permeability, including Crohn's disease, ulcerative colitis, gastritis
  • taking dietary supplements other than those given in the study
  • abnormal liver function, CBC, or thyroid values
  • individuals taking any drug or medication, prescription or over the counter, including Isoniazid, Saquinavir, Warfarin, Cyclosporine, Acetaminophen, Oxazepam, medications used for HIV/ AIDS, blood clotting, birth control pills, fish oil and medications metabolized by CYPs (CYP1A2, CYP2E1 and CYP3A4) during the dosing period of 1 week and 48 h prior to and after dosing. Exceptions may be made by the study MD and the PI if in their opinion a medication will not interfere with the scientific validity of the study. The study MD will evaluate a medication on a case-by-case basis to determine that efficacy and safety are not adversely affected.
  • Individuals who are known to have problems with blood clotting or increased bleeding, including hemophiliacs or anyone recently undergoing or recovering from a surgical procedure.
  • soy or garlic allergy
Both
20 Years and older
Yes
Contact: Mohaiza Dashwood 541-737-9375 mohaiza.dashwood@oregonstate.edu
United States
 
NCT01543074
CA122959
No
Oregon State University
Oregon State University
Not Provided
Principal Investigator: Rod Dashwood, PhD Oregon State University
Oregon State University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP