Dietary Histone Deacetylase Inhibitors (HDAC)

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
HDAC Activity
Drug: BSE placebo & garlic oil placebo
Dietary Supplement: garlic oil plus BSE placebo
Dietary Supplement: BSE plus garlic oil placebo
Dietary Supplement: BSE & Garlic Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Dietary HDAC Inhibitors

Resource links provided by NLM:


Further study details as provided by Oregon State University:

Primary Outcome Measures:
  • HDAC activity [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Change in HDAC activity.


Secondary Outcome Measures:
  • Histone acetylation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Change in histone acetylation


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BSE placebo & garlic oil placebo
Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
Drug: BSE placebo & garlic oil placebo
see arm description
Dietary Supplement: BSE & Garlic Oil
see arm description
Active Comparator: garlic oil plus BSE placebo
one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
Drug: BSE placebo & garlic oil placebo
see arm description
Dietary Supplement: BSE plus garlic oil placebo
see arm description
Active Comparator: BSE plus garlic oil placebo
two BSE capsules plus one garlic oil placebo capsule per day for seven days
Dietary Supplement: garlic oil plus BSE placebo
see arm description
Dietary Supplement: BSE & Garlic Oil
see arm description
Active Comparator: BSE & Garlic Oil
two BSE and one garlic oil capsule per day for seven days
Dietary Supplement: garlic oil plus BSE placebo
see arm description
Dietary Supplement: BSE plus garlic oil placebo
see arm description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543074

Contacts
Contact: Mohaiza Dashwood 541-737-9375 mohaiza.dashwood@oregonstate.edu

Locations
United States, Oregon
Oregon State University Recruiting
Corvallis, Oregon, United States, 97331
Contact: Mohaiza Dashwood    541-737-9375    mohaiza.dashwood@oregonstate.edu   
Principal Investigator: Rod Dashwood, PhD         
Sponsors and Collaborators
Oregon State University
Investigators
Principal Investigator: Rod Dashwood, PhD Oregon State University
  More Information

No publications provided

Responsible Party: Oregon State University
ClinicalTrials.gov Identifier: NCT01543074     History of Changes
Other Study ID Numbers: CA122959
Study First Received: February 17, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Oregon State University:
HDAC
histone acetylation
broccoli sprout extract
garlic oil
PBMCs

Additional relevant MeSH terms:
Allyl sulfide
Histone Deacetylase Inhibitors
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014