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Xanthohumol and Prevention of DNA Damage

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ClinicalTrials.gov Identifier: NCT02432651
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jan Frederik Stevens, Oregon State University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Drug: 6 mg xanthohumol per day Drug: 12 mg xanthohumol per day Drug: 24 mg xanthohumol per day Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Oxidative DNA Damage by Xanthohumol
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
6 mg xanthohumol per day vs. placebo
All participants take 6 mg xanthohumol daily and placebo in a crossover design with a washout period.
 Drug: 6 mg xanthohumol per day
Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.

Drug: Placebo
Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.
12 mg xanthohumol per day vs. placebo
All participants take 12 mg xanthohumol daily and placebo in a crossover design with a washout period.
 Drug: 12 mg xanthohumol per day
Participants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks.

Drug: Placebo
Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.
24 mg xanthohumol per day vs. placebo
All participants take 24 mg xanthohumol daily and placebo in a crossover design with a washout period.
 Drug: 24 mg xanthohumol per day
Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.

Drug: Placebo
Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432651


Locations
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United States, Oregon
Oregon State University
Corvallis, Oregon, United States, 97331
Sponsors and Collaborators
Oregon State University
Investigators
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Principal Investigator: Jan Frederik Stevens, PhD Oregon State University
More Information
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Responsible Party: Jan Frederik Stevens, Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences, College of Pharmacy, Oregon State University
ClinicalTrials.gov Identifier: NCT02432651    
Other Study ID Numbers: LPI-6119
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jan Frederik Stevens, Oregon State University:
oxidative stress
hops
xanthohumol
DNA damage
cancer
Additional relevant MeSH terms:
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Xanthohumol
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Growth Inhibitors