Xanthohumol and Prevention of DNA Damage

NCT02432651 | Completed Phase 1 DMC

• 1 other identifier: LPI-6119
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Keywords

oxidative stress; hops; xanthohumol; DNA damage; cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of the change in metabolic profile during XN treatment vs. the change during placebo

  Prior to first dose on day 1 to day 63.

Study Arms (3)

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.

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.

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.

Drug: 24 mg xanthohumol per day; Drug: Placebo

Interventions

6 mg xanthohumol per day DRUG

Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.

6 mg xanthohumol per day vs. placebo

12 mg xanthohumol per day DRUG

Participants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks.

12 mg xanthohumol per day vs. placebo

24 mg xanthohumol per day DRUG

Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.

24 mg xanthohumol per day vs. placebo

Placebo DRUG

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; 24 mg xanthohumol per day vs. placebo; 6 mg xanthohumol per day vs. placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jan Frederik Stevens, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences, College of Pharmacy

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: May 4, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)