Histone Deacetylase (HDAC) ActivityNCT01543074
Dietary Histone Deacetylase Inhibitors (HDAC)
A study testing Garlic oil and BSE in people with Histone Deacetylase (HDAC) Activity, run by Texas A&M University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Histone Deacetylase (HDAC) Activity
- What is being tested?
- Garlic oil and BSE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Histone Deacetylase (HDAC) Activity
- Being tested
- BSE placebo, Garlic oil, BSE, Garlic Oil Placebo
- Keywords
- HDAC, histone acetylation, broccoli sprout extract, garlic oil, PBMCs
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSE placeboDietary supplement
Also called Placebo for Broccoli Sprout Extract
2 pills = 0 micromoles of Sulforaphane/day
Garlic oilDietary supplement
Also called Schiff Super Garlic
1 pill = 30 mg garlic oil/day
BSEDrug
Also called Broccoli Sprout Extract
2 pills = 200 micromoles of Sulforaphane/day
Garlic Oil PlaceboDietary supplement
Also called Placebo for Schiff Super Garlic
1 pill = 0 mg garlic oil/day
| Study group | Role | What they receive |
|---|---|---|
| BSE placebo & garlic oil placebo | Placebo comparator | Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days Receives: Dietary Supplement: BSE placebo; Dietary 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 Receives: Dietary Supplement: BSE placebo; Dietary Supplement: Garlic oil |
| BSE plus garlic oil placebo | Active comparator | two BSE capsules plus one garlic oil placebo capsule per day for seven days Receives: Drug: BSE; Dietary Supplement: Garlic Oil Placebo |
| BSE & Garlic Oil | Active comparator | two BSE and one garlic oil capsule per day for seven days Receives: Dietary Supplement: Garlic oil; Drug: BSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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
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".
Measured: 6 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Histone Deacetylase (HDAC) ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick Dashwood, Texas A&M University
- Investigators
- Roderick Dashwood, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543074
- Sponsor's protocol ID
- CA122959
- Status last verified
- Apr 2019
- First submitted
- 17 Feb 2012
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26388957
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Histone Deacetylase (HDAC) Inhibitors
- ClinicalTrials.gov ID
- NCT01543074
- Acronym / sponsor ID
- CA122959
- Conditions
- Histone Deacetylase (HDAC) Activity
- Keywords
- HDAC, histone acetylation, broccoli sprout extract, garlic oil, PBMCs
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 10 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BSE placebo & garlic oil placebo | Placebo comparator | Dietary Supplement: BSE placebo, Dietary Supplement: Garlic Oil PlaceboTwo BSE placebo capsules and one garlic oil placebo capsule per day for seven days |
| garlic oil plus BSE placebo | Active comparator | Dietary Supplement: BSE placebo, Dietary Supplement: Garlic oilone garlic oil capsule plus 2 BSE placebo capsules per day for seven days |
| BSE plus garlic oil placebo | Active comparator | Drug: BSE, Dietary Supplement: Garlic Oil Placebotwo BSE capsules plus one garlic oil placebo capsule per day for seven days |
| BSE & Garlic Oil | Active comparator | Dietary Supplement: Garlic oil, Drug: BSEtwo BSE and one garlic oil capsule per day for seven days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSE placeboAlso: Placebo for Broccoli Sprout Extract2 pills = 0 micromoles of Sulforaphane/day | Dietary supplement | BSE placebo & garlic oil placebo, garlic oil plus BSE placebo |
| Garlic oilAlso: Schiff Super Garlic1 pill = 30 mg garlic oil/day | Dietary supplement | BSE & Garlic Oil, garlic oil plus BSE placebo |
| BSEAlso: Broccoli Sprout Extract2 pills = 200 micromoles of Sulforaphane/day | Drug | BSE & Garlic Oil, BSE plus garlic oil placebo |
| Garlic Oil PlaceboAlso: Placebo for Schiff Super Garlic1 pill = 0 mg garlic oil/day | Dietary supplement | BSE placebo & garlic oil placebo, BSE plus garlic oil placebo |
Primary outcome
Cmax of Sulforaphane and Its Metabolites in Blood
Time frame: 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
Time frame: 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".
1 secondary outcome
Histone Acetylation
Time frame: 6 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26388957Rajendran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roderick Dashwood, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic oil and BSE in people with Histone Deacetylase (HDAC) Activity, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Sulforaphane and Its Metabolites in Blood (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.