Dietary Histone Deacetylase Inhibitors (HDAC)

This study is not yet open for participant recruitment.

Verified February 2012 by Oregon State University

Sponsor:

Information provided by (Responsible Party):

Oregon State University

ClinicalTrials.gov Identifier:

NCT01543074

First received: February 17, 2012

Last updated: March 1, 2012

Last verified: February 2012

History of Changes

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 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	Dietary Supplement: Broccoli sprout extract (BSE) placebo Dietary Supplement: Broccoli sprout extract (BSE) capsules Dietary Supplement: garlic oil capsules Dietary Supplement: garlic oil placebo

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

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 actylation

Estimated Enrollment:	80
Study Start Date:	April 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (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	Dietary Supplement: Broccoli sprout extract (BSE) placebo see arm description Dietary Supplement: garlic oil placebo see arm description
Active Comparator: garlic oil plus BSE placebo one garlic oil capsule plus 2 BSE placebo capsules per day for seven days	Dietary Supplement: Broccoli sprout extract (BSE) placebo see arm description Dietary Supplement: garlic oil capsules 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: Broccoli sprout extract (BSE) capsules see arm description Dietary Supplement: garlic oil placebo see arm description
Active Comparator: BSE & Garlic Oil two BSE and one garlic oil capsule per day for seven days	Dietary Supplement: Broccoli sprout extract (BSE) capsules see arm description Dietary Supplement: garlic oil capsules 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 1 week before and 3 weeks during the trial for a total of 4 weeks (a list will be provided)

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
concurrent medications that may affect gastrointestinal absorption or alter gastric motility including: cholestyramine, sucralfate, H2 antagonists, proton pump inhibitors, pro-motility agents, anti-motility agents (anti-diarrheal medications)
taking dietary supplements other than those given in the study
abnormal liver function or thyroid values
individuals taking Isoniazid, Warfarin, or anti-retroviral medications.

Contacts and Locations

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

Contacts

Contact: Mary Garrard

541-737-1885

mary.garrard@oregonstate.edu

Locations

United States, Oregon
Oregon State University	Not yet recruiting
Corvallis, Oregon, United States, 97331
Contact: Mary Garrard 541-737-1885 mary.garrard@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:	March 1, 2012
Health Authority:	United States: Institutional Review Board

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 October 17, 2012

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