Colorectal AdenomaNCT03268655
Ginger and Gut Microbiome (GINGER)
A study testing Ginger extract in people with Colorectal Adenoma, run by University of Minnesota at 13 sites in United States.
Trial 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.. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Ginger extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 13 sitesUnited States
- Study dates
- 14 Nov 2018to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal adenoma diagnosis
Who cannot join
- Allergy or sensitivity to ginger
- Active cancer
- Unstable medical condition
- Unstable diet or weight
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Mayo Clinic Cancer Center
Albert Lea, Minnesota, 56007
Mayo Clinic Cancer Center
Austin, Minnesota, 55912
Essentia Health - Deer River
Deer River, Minnesota, 56636
Essentia Health St Mary's - Detroit Lakes
Detroit Lakes, Minnesota, 56501
Essentia Health - Fosston Clinic
Fosston, Minnesota, 56542
Fairview Grand Itasca Clinic & Hospital
Grand Rapids, Minnesota, 55744
Fairview Range Medical Center
Hibbing, Minnesota, 55746
Mayo Clinic Cancer System
Mankato, Minnesota, 56001
Epidemiology Clinical Research Center
Minneapolis, Minnesota, 55415
Monticello Cancer Center
Monticello, Minnesota, 55362
Essentia Health - Park Rapids Clinic
Park Rapids, Minnesota, 56470
Fairview Northland Medical Center
Princeton, Minnesota, 55371
Essentia Health -Virgina Clinic
Virginia, Minnesota, 55792
About this study
Official title: Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
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..
Read the detailed description
This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal adenoma within the last five years. There will be 47-50 subjects in the treatment group and 47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of ginger extract per day (1000 mg twice a day) or matching placebo.
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:
- 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.
- 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
- Colorectal Adenoma
- Being tested
- Ginger extract, Placebo
- Keywords
- gingerol, microbiome, gut, ginger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger extractDietary supplement
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
PlaceboOther
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
| Study group | Role | What they receive |
|---|---|---|
| Ginger extract | Experimental | Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout. Receives: Dietary Supplement: Ginger extract |
| Placebo | Experimental | Placebo, daily for 6 weeks, followed by 6 week washout. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Baseline to 6 weeks
Secondary outcomes (1)
Change in gut microbiome composition
Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start14 Nov 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot. Double-blind placebo-controlled randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Prizment, PhD, MPH, Principal investigator, University of Minnesota, Epidemiology and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268655
- Sponsor's protocol ID
- SPH-2017-25928
- Other IDs
- Anna-CPRC-TBD
- Status last verified
- Jul 2020
- First submitted
- 25 Aug 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
- ClinicalTrials.gov ID
- NCT03268655
- Acronym / sponsor ID
- SPH-2017-25928
- Conditions
- Colorectal Adenoma
- Keywords
- gingerol, microbiome, gut, ginger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal adenoma within the last five years. There will be 47-50 subjects in the treatment group and 47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of ginger extract per day (1000 mg twice a day) or matching placebo.
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:
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Pilot. Double-blind placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Ginger extract | Experimental | Dietary Supplement: Ginger extractGinger extract, 2000 mg daily for 6 weeks, followed by 6 week washout. |
| Placebo | Experimental | Other: PlaceboPlacebo, daily for 6 weeks, followed by 6 week washout. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal adenoma diagnosis
Key exclusion criteria (4 listed)
- Allergy or sensitivity to ginger
- Active cancer
- Unstable medical condition
- Unstable diet or weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger extract2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout | Dietary supplement | Ginger extract |
| Placebo2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout | Other | Placebo |
Primary outcome
Composition of the gut microbiome
Time frame: Baseline to 6 Weeks
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).
Urine inflammatory biomarker
Time frame: Baseline to 6 weeks
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
1 secondary outcome
Change in gut microbiome composition
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Prizment, PhD, MPH principal investigator
University of Minnesota, Epidemiology and Community Health
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger extract in people with Colorectal Adenoma, run by University of Minnesota at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the gut microbiome (time frame: Baseline to 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.