Xanthohumol and Prevention of DNA Damage

Oxidative Stress Clinical Trial

Official title:

Prevention of Oxidative DNA Damage by Xanthohumol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432651
• Other study ID #: LPI-6119
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: November 2018
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Drug:
• 6 mg xanthohumol per day
Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
• 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.
• 24 mg xanthohumol per day
Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
• Placebo
Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Prior to first dose on day 1 to day 63.
Secondary	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.	Prior to first dose on day 1 to day 63.