Dietary Histone Deacetylase Inhibitors (HDAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roderick Dashwood, Texas A&M University
ClinicalTrials.gov Identifier:
NCT01543074
First received: February 17, 2012
Last updated: October 17, 2014
Last verified: October 2014

February 17, 2012
October 17, 2014
March 2013
December 2013   (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 Histone Deacetylase (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.

Study participants attend a pre-study meeting either individually or with several other potential volunteers according to their preference. The study is described in detail and participants are given the opportunity to ask questions. If participants agree to participate, they will sign the consent form. Height and weight will be measured privately.

Food diary forms will be distributed and taught how to use. A 4ml (1 tsp) blood sample will be drawn for a pre-study blood chemistry, CBC and thyroid tests. Samples for all clinical labs done during the study will be sent to Good Samaritan Hospital, a CLIA-certified laboratory, on a fee-for-service basis.

The study MD will evaluate the lab results. If the tests are abnormal as determined by the study MD, the participant will be excluded from the study and advised to see their doctor for evaluation.

Subjects will observe dietary restrictions starting one week before Day 1 of the study and continuing through Day 14 (total of 3 weeks). Dietary restrictions are listed on the last page of the diet recall forms.

Women with negative urine pregnancy test on the morning of Day 1 will be enrolled in the study. About 20 ml fasting blood will be drawn on the morning of Day 1. Breakfast will be provided and 3 capsules given to swallow. (One capsule will be garlic oil or garlic oil placebo, the other two will be BSE or BSE placebo.) No eating or drinking (except water) until the next blood draws at 1,3 6 hours after breakfast.

Participants will come to the study site for the next seven days to consume the standard breakfast and study capsules, or we may send the breakfast and study capsules home with participants for the weekend. Blood will be sampled immediately before breakfast on day 7 and again at 1, 3, 6, 24 and 48 hours later. We will provide a standardized lunch to all participants on Days 1 and 7. Additional blood draws will occur at the end of week 2 (i.e. on day 14 of the study). The study will end after 2 weeks.

Participants will fill out a dietary recall form three random times during the study on two week days and one weekend day.

Urine will be collected on the following schedule: Day 1, 0-3 hours, 3-6 hours, 6-12 hours,12-24 hours, 24-48 hours; Day 7, 0-3 hours, 3-6 hours, 6-12 hours, 12-24 hours, 24-48 hours. Total urine from each interval will be collected and pooled in separate containers. We will provide the proper containers for urine collection. Urine may be stored at room temperature.

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.
 
Completed
34
December 2013
December 2013   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT01543074
CA122959
No
Roderick Dashwood, Texas A&M University
Texas A&M University
Not Provided
Principal Investigator: Roderick Dashwood, PhD Texas A&M University Health Science Center
Texas A&M University
October 2014

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