NCT01543074

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 10, 2015

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

February 17, 2012

Results QC Date

June 1, 2015

Last Update Submit

April 8, 2019

Conditions

Histone Deacetylase (HDAC) Activity

Keywords

HDAChistone acetylationbroccoli sprout extractgarlic oilPBMCs

Outcome Measures

Primary Outcomes (2)

  • Cmax of Sulforaphane and Its Metabolites in Blood

    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".

    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.

  • Tmax of Sulforaphane and Its Metabolites in Blood

    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".

    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.

Secondary Outcomes (1)

  • Histone Acetylation

    6 h

Study Arms (4)

BSE placebo & garlic oil placebo

PLACEBO COMPARATOR

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

Dietary Supplement: BSE placeboDietary Supplement: Garlic Oil Placebo

garlic oil plus BSE placebo

ACTIVE COMPARATOR

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

Dietary Supplement: BSE placeboDietary Supplement: Garlic oil

BSE plus garlic oil placebo

ACTIVE COMPARATOR

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

Drug: BSEDietary Supplement: Garlic Oil Placebo

BSE & Garlic Oil

ACTIVE COMPARATOR

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

Dietary Supplement: Garlic oilDrug: BSE

Interventions

BSE placeboDIETARY_SUPPLEMENT

2 pills = 0 micromoles of Sulforaphane/day

Also known as: Placebo for Broccoli Sprout Extract
BSE placebo & garlic oil placebogarlic oil plus BSE placebo
Garlic oilDIETARY_SUPPLEMENT

1 pill = 30 mg garlic oil/day

Also known as: Schiff Super Garlic
BSE & Garlic Oilgarlic oil plus BSE placebo
BSEDRUG

2 pills = 200 micromoles of Sulforaphane/day

Also known as: Broccoli Sprout Extract
BSE & Garlic OilBSE plus garlic oil placebo
Garlic Oil PlaceboDIETARY_SUPPLEMENT

1 pill = 0 mg garlic oil/day

Also known as: Placebo for Schiff Super Garlic
BSE placebo & garlic oil placeboBSE plus garlic oil placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

  • Rajendran P, Dashwood WM, Li L, Kang Y, Kim E, Johnson G, Fischer KA, Lohr CV, Williams DE, Ho E, Yamamoto M, Lieberman DA, Dashwood RH. Nrf2 status affects tumor growth, HDAC3 gene promoter associations, and the response to sulforaphane in the colon. Clin Epigenetics. 2015 Sep 18;7(1):102. doi: 10.1186/s13148-015-0132-y. eCollection 2015.

    PMID: 26388957RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

allyl sulfide

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Early termination (23/80) due to small numbers of subjects recruited.

Results Point of Contact

Title
Rod Dashwood
Organization
Institute of Biosciences and Technology, Texas A&M Health Science Center, Houston TX
rdashwood@ibt.tamhsc.edu
7136777806

Study Officials

  • Roderick Dashwood, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Center for Epigenetics & Disease Prevention

Study Record Dates

First Submitted

February 17, 2012

First Posted

March 2, 2012

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 30, 2019

Results First Posted

September 10, 2015

Record last verified: 2019-04

Locations

US(1)