Dietary Histone Deacetylase Inhibitors (HDAC)

Not Applicable

Terminated

Conditions: Histone Deacetylase (HDAC) Activity

Interventions: Dietary Supplement: BSE placebo
Dietary Supplement: Garlic oil
Dietary Supplement: Garlic Oil Placebo
Drug: BSE

Registration Number: NCT01543074

Lead Sponsor: Texas A&M University

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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
garlic oil plus BSE placebo	Garlic oil	one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE plus garlic oil placebo	Garlic Oil Placebo	two BSE capsules plus one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo	BSE placebo	Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
BSE placebo & garlic oil placebo	Garlic Oil Placebo	Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days
garlic oil plus BSE placebo	BSE placebo	one garlic oil capsule plus 2 BSE placebo capsules per day for seven days
BSE & Garlic Oil	BSE	two BSE and one garlic oil capsule per day for seven days
BSE plus garlic oil placebo	BSE	two BSE capsules plus one garlic oil placebo capsule per day for seven days
BSE & Garlic Oil	Garlic oil	two BSE and one garlic oil capsule per day for seven days

Primary Outcome Measures

Name	Time	Method
Cmax of Sulforaphane and Its Metabolites in Blood	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.	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".
Tmax of Sulforaphane and Its Metabolites in Blood	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.	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".

Secondary Outcome Measures

Name	Time	Method
Histone Acetylation	6 h	Histone acetylation was measured by immunoblotting the levels of acetylated histone H4K12 in the circulating peripheral blood mononuclear cells (PBMCs) of subjects who consumed either placebo, garlic oil, BSE, or BSE+garlic oil. The fold increase in acetylated histone H4K12 in the different groups is shown in the "Outcome Measure Data Table".