Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2018-11-14
2020-06-26
Brief Summary
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Detailed Description
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Subjects will provide three stool specimens for analysis of the intestinal microbiome over a 12-week period at the following intervals: Week 0 (Day 1), Week 6, and Week 12. Although the gut microbiome is stable within a period of 1-2 months, a control arm will be included to account for potential dietary and other changes that may affect the gut microbiome. Gut microbiome composition - the presence, abundance, and diversity of bacterial taxa - will be derived by sequencing microbial 16S ribosomal RNA genes.
Primary Aims:
Aim 1 is to estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects.
Aim 2 will examine the correlation between the ginger-related changes in microbiome profile with the levels of circulating biomarkers: urinary Prostaglandin E (PGE) metabolites.
Hypothesis: In the ginger versus placebo arm, gut microbiome will shift towards a lower proportion of pro-inflammatory, bacteria associated with colorectal cancer (CRC) and higher proportion of anti-inflammatory, CRC-protective bacteria.
Secondary Aim:
1. At the end of the study, we expect to show that ginger decreases the relative abundance of pro-inflammatory, CRC-predisposing taxa and increases the abundance of anti-inflammatory, CRC-protective taxa, i.e., demonstrate that ginger boosts changes in gut microbiome that are protective against CRC, as well as assess ginger-induced changes in immune response.
2. The similarities of bacterial profiles will be compared between three time points baseline and 6 Weeks and 12 Weeks to estimate whether 6-week is a sufficient time for washout.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Ginger extract
Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
Ginger extract
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Placebo
Placebo, daily for 6 weeks, followed by 6 week washout.
Placebo
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Interventions
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Ginger extract
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Placebo
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active cancer
* Unstable medical condition
* Unstable diet or weight
50 Years
75 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Anna Prizment, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota, Epidemiology and Community Health
Locations
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Mayo Clinic Cancer Center
Albert Lea, Minnesota, United States
Mayo Clinic Cancer Center
Austin, Minnesota, United States
Essentia Health - Deer River
Deer River, Minnesota, United States
Essentia Health St Mary's - Detroit Lakes
Detroit Lakes, Minnesota, United States
Essentia Health - Fosston Clinic
Fosston, Minnesota, United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, United States
Fairview Range Medical Center
Hibbing, Minnesota, United States
Mayo Clinic Cancer System
Mankato, Minnesota, United States
Epidemiology Clinical Research Center
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
Essentia Health - Park Rapids Clinic
Park Rapids, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
Essentia Health -Virgina Clinic
Virginia, Minnesota, United States
Countries
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Other Identifiers
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Anna-CPRC-TBD
Identifier Type: OTHER
Identifier Source: secondary_id
SPH-2017-25928
Identifier Type: -
Identifier Source: org_study_id
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