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临床试验/NCT01543074
NCT01543074终止不适用

Dietary Histone Deacetylase (HDAC) Inhibitors

Texas A&M University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
1
主要终点
Cmax of Sulforaphane and Its Metabolites in Blood

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

BSE placebo & garlic oil placebo

Placebo Comparator

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

干预措施: BSE placebo (Dietary Supplement)

BSE placebo & garlic oil placebo

Placebo Comparator

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

干预措施: Garlic Oil Placebo (Dietary Supplement)

garlic oil plus BSE placebo

Active Comparator

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

干预措施: BSE placebo (Dietary Supplement)

garlic oil plus BSE placebo

Active Comparator

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

干预措施: Garlic oil (Dietary Supplement)

BSE plus garlic oil placebo

Active Comparator

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

干预措施: BSE (Drug)

BSE plus garlic oil placebo

Active Comparator

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

干预措施: Garlic Oil Placebo (Dietary Supplement)

BSE & Garlic Oil

Active Comparator

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

干预措施: Garlic oil (Dietary Supplement)

BSE & Garlic Oil

Active Comparator

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

干预措施: BSE (Drug)

结局指标

主要结局

Cmax of Sulforaphane and Its Metabolites in Blood

时间窗: 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

时间窗: 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".

次要结局

  • Histone Acetylation(6 h)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roderick Dashwood

Director Center for Epigenetics & Disease Prevention

Texas A&M University

研究点 (1)

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