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Ginger and Gut Microbiome (GINGER)

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ClinicalTrials.gov Identifier: NCT03268655
Recruitment Status : Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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..

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Dietary Supplement: Ginger extract Other: Placebo Not Applicable

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:

  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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot. Double-blind placebo-controlled randomized trial
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Basic Science
Official Title: Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ginger extract
Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
Dietary Supplement: Ginger extract
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Experimental: Placebo
Placebo, daily for 6 weeks, followed by 6 week washout.
Other: Placebo
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout



Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. Change in gut microbiome composition [ Time Frame: Baseline to 12 weeks ]
    Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal adenoma diagnosis

Exclusion Criteria:

  • Allergy or sensitivity to ginger
  • Active cancer
  • Unstable medical condition
  • Unstable diet or weight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268655


Contacts
Contact: Anna Prizment, PhD, MPH 612-626-0250 prizm001@umn.edu
Contact: Allison Iwan, BS 612-626-4816 iwanx003@umn.edu

Locations
United States, Minnesota
Epidemiology Clinical Research Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Anna Prizment, PhD, MPH University of Minnesota, Epidemiology and Community Health

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03268655     History of Changes
Other Study ID Numbers: Anna- IRB-TBD
Anna-CPRC-TBD ( Other Identifier: UMN Clinical Protocol Review Committee )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
gingerol
microbiome
gut
ginger

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms