Ginger and Gut Microbiome (GINGER)
Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
2 other identifiers
interventional
68
1 country
13
Brief Summary
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
November 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedJuly 22, 2020
July 1, 2020
1.6 years
August 25, 2017
July 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composition of the gut microbiome
Fecal microbial diversity and the prevalence of specific taxa associated with colorectal cancer (e.g. Fusobacteria, butyrate producing bacteria) will be estimated at 6 weeks. The ginger-related changes in the prevalence of each taxon will be assessed individually and also combined into a microbiome index (the abundance of protective taxa will be included as a negative value).
Baseline to 6 Weeks
Urine inflammatory biomarker
Urinary metabolite of Prostaglandin E2 (ng/mg of creatinine) will be measured before and after treatment with ginger. Changes in inflammatory markers will be correlated to changes in the microbial diversity and the microbiome composition
Baseline to 6 weeks
Secondary Outcomes (1)
Change in gut microbiome composition
Baseline to 12 weeks
Study Arms (2)
Ginger extract
EXPERIMENTALGinger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
Placebo
EXPERIMENTALPlacebo, daily for 6 weeks, followed by 6 week washout.
Interventions
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Eligibility Criteria
You may qualify if:
- Colorectal adenoma diagnosis
You may not qualify if:
- Allergy or sensitivity to ginger
- Active cancer
- Unstable medical condition
- Unstable diet or weight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Mayo Clinic Cancer Center
Albert Lea, Minnesota, 56007, United States
Mayo Clinic Cancer Center
Austin, Minnesota, 55912, United States
Essentia Health - Deer River
Deer River, Minnesota, 56636, United States
Essentia Health St Mary's - Detroit Lakes
Detroit Lakes, Minnesota, 56501, United States
Essentia Health - Fosston Clinic
Fosston, Minnesota, 56542, United States
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744, United States
Fairview Range Medical Center
Hibbing, Minnesota, 55746, United States
Mayo Clinic Cancer System
Mankato, Minnesota, 56001, United States
Epidemiology Clinical Research Center
Minneapolis, Minnesota, 55415, United States
Monticello Cancer Center
Monticello, Minnesota, 55362, United States
Essentia Health - Park Rapids Clinic
Park Rapids, Minnesota, 56470, United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371, United States
Essentia Health -Virgina Clinic
Virginia, Minnesota, 55792, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Prizment, PhD, MPH
University of Minnesota, Epidemiology and Community Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
August 31, 2017
Study Start
November 14, 2018
Primary Completion
June 26, 2020
Study Completion
June 26, 2020
Last Updated
July 22, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share
The results of the study will be disseminated to various stakeholders through the publication of a manuscript in a peer-reviewed journal and through presentation at scientific meetings.