Oxidative StressPhase 1NCT02432651
Xanthohumol and Prevention of DNA Damage
A Phase 1 study testing 6 mg xanthohumol per day, 12 mg xanthohumol per day and 24 mg xanthohumol per day in people with Oxidative Stress, run by Oregon State University at 1 site in United States.
Trial summary
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- 6 mg xanthohumol per day, 12 mg xanthohumol per day and 24 mg xanthohumol per day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers or no other tobacco use in the past 3 months.
- Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study.
- Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study.
- Must be able to give written informed consent.
- Blood screen tests (Comprehensive metabolic profile [CMP] and lipid profile) within normal limits.
Who cannot join
- Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese)
- Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study.
- Currently taking prescription drugs except oral contraceptives.
- Consumption of more than the recommended alcohol guidelines i.e. >2 drinks/day.
- Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers).
- Pregnancy (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study.
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- Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis), using UV tanning beds, or unprotected sun exposure greater than 1 hour per day.
- Engaging in vigorous exercise more than 6 hours per week.
- Participation in another dietary study in the past 3 months.
- Had surgery in the last 3 months.
- Post-menopausal status
- (Note: Beverage is formulated with a barley extract. Barley contains gluten.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Oxidative DNA Damage by Xanthohumol
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Read the detailed description
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Participants will consume a non-alcoholic beverage containing xanthohumol with breakfast, lunch and dinner for 3 weeks. Then they will go through a washout period of 3 weeks. And then they will consume the same beverage without the xanthohumol compound (placebo) for another 3 weeks. Participants will be randomly assigned into groups and will vary whether they will consume the xanthohumol product during the first or second 3-week period. Xanthohumol doses will be 0, 6, 12 or 24 mg/day.
The study includes donation of blood and urine samples and one-month food frequency questionnaires.
- Conditions
- Oxidative Stress
- Being tested
- 6 mg xanthohumol per day, 12 mg xanthohumol per day, 24 mg xanthohumol per day, Placebo
- Keywords
- oxidative stress, hops, xanthohumol, DNA damage, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 mg xanthohumol per dayDrug
Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
12 mg xanthohumol per dayDrug
Participants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks.
24 mg xanthohumol per dayDrug
Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
PlaceboDrug
Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 6 mg xanthohumol per day vs. placebo | Other | All participants take 6 mg xanthohumol daily and placebo in a crossover design with a washout period. Receives: Drug: 6 mg xanthohumol per day; Drug: Placebo |
| 12 mg xanthohumol per day vs. placebo | Other | All participants take 12 mg xanthohumol daily and placebo in a crossover design with a washout period. Receives: Drug: 12 mg xanthohumol per day; Drug: Placebo |
| 24 mg xanthohumol per day vs. placebo | Other | All participants take 24 mg xanthohumol daily and placebo in a crossover design with a washout period. Receives: Drug: 24 mg xanthohumol per day; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change in markers of DNA damage and oxidative stress during XN treatment vs. the change during placebo
Plasma and urine levels of 8-oxo-dG will be measured at the beginning and end of each 3-week cycle. DNA strand breaks in blood cells and plasma levels of reduced and oxidized glutathione will be measured at the beginning and end of each 3-week cycle. Between the two cycles, there will be a 3-week washout. One cycle is XN treatment, and one cycle is the placebo.
Measured: Prior to first dose on day 1 to day 63.
Secondary outcomes (1)
Comparison of the change in metabolic profile during XN treatment vs. the change during placebo
Metabolome measurements in plasma at beginning and end of first 3-week cycle with 3-week. Between the two cycles, there will be a 3-week washout period between cycles. One cycle is XN treatment, and one cycle is the placebo.
Measured: Prior to first dose on day 1 to day 63.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Frederik Stevens, Oregon State University
- Investigators
- Jan Frederik Stevens, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432651
- Sponsor's protocol ID
- LPI-6119
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Oxidative DNA Damage by Xanthohumol
- ClinicalTrials.gov ID
- NCT02432651
- Acronym / sponsor ID
- LPI-6119
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress, hops, xanthohumol, DNA damage, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Detailed description
The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer.
Participants will consume a non-alcoholic beverage containing xanthohumol with breakfast, lunch and dinner for 3 weeks. Then they will go through a washout period of 3 weeks. And then they will consume the same beverage without the xanthohumol compound (placebo) for another 3 weeks. Participants will be randomly assigned into groups and will vary whether they will consume the xanthohumol product during the first or second 3-week period. Xanthohumol doses will be 0, 6, 12 or 24 mg/day.
The study includes donation of blood and urine samples and one-month food frequency questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 mg xanthohumol per day vs. placebo | Other | Drug: 6 mg xanthohumol per day, Drug: PlaceboAll participants take 6 mg xanthohumol daily and placebo in a crossover design with a washout period. |
| 12 mg xanthohumol per day vs. placebo | Other | Drug: 12 mg xanthohumol per day, Drug: PlaceboAll participants take 12 mg xanthohumol daily and placebo in a crossover design with a washout period. |
| 24 mg xanthohumol per day vs. placebo | Other | Drug: 24 mg xanthohumol per day, Drug: PlaceboAll participants take 24 mg xanthohumol daily and placebo in a crossover design with a washout period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smokers or no other tobacco use in the past 3 months.
- Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study.
- Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study.
- Must be able to give written informed consent.
- Blood screen tests (Comprehensive metabolic profile [CMP] and lipid profile) within normal limits.
Key exclusion criteria (12 listed)
- Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese)
- Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study.
- Currently taking prescription drugs except oral contraceptives.
- Consumption of more than the recommended alcohol guidelines i.e. >2 drinks/day.
- Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers).
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 |
|---|---|---|
| 6 mg xanthohumol per dayParticipants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks. | Drug | 6 mg xanthohumol per day vs. placebo |
| 12 mg xanthohumol per dayParticipants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks. | Drug | 12 mg xanthohumol per day vs. placebo |
| 24 mg xanthohumol per dayParticipants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks. | Drug | 24 mg xanthohumol per day vs. placebo |
| PlaceboParticipants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks. | Drug | 12 mg xanthohumol per day vs. placebo, 24 mg xanthohumol per day vs. placebo, 6 mg xanthohumol per day vs. placebo |
Primary outcome
Comparison of the change in markers of DNA damage and oxidative stress during XN treatment vs. the change during placebo
Time frame: Prior to first dose on day 1 to day 63.
Plasma and urine levels of 8-oxo-dG will be measured at the beginning and end of each 3-week cycle. DNA strand breaks in blood cells and plasma levels of reduced and oxidized glutathione will be measured at the beginning and end of each 3-week cycle. Between the two cycles, there will be a 3-week washout. One cycle is XN treatment, and one cycle is the placebo.
1 secondary outcome
Comparison of the change in metabolic profile during XN treatment vs. the change during placebo
Time frame: Prior to first dose on day 1 to day 63.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Jan Frederik Stevens, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 6 mg xanthohumol per day, 12 mg xanthohumol per day and 24 mg xanthohumol per day in people with Oxidative Stress, run by Oregon State 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 6 Nov 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the change in markers of DNA damage and oxidative stress during XN treatment vs. the change during placebo (time frame: Prior to first dose on day 1 to day 63.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.