Ginger and Gut Microbiome (GINGER)

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..

Study Overview

• Status: Completed
• Conditions: Colorectal Adenoma
• Intervention / Treatment: Dietary supplement: Ginger extract; Other: Placebo

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
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Albert Lea, Minnesota, United States, 56007
      • Mayo Clinic Cancer Center
    • Austin, Minnesota, United States, 55912
      • Mayo Clinic Cancer Center
    • Deer River, Minnesota, United States, 56636
      • Essentia Health - Deer River
    • Detroit Lakes, Minnesota, United States, 56501
      • Essentia Health St Mary's - Detroit Lakes
    • Fosston, Minnesota, United States, 56542
      • Essentia Health - Fosston Clinic
    • Grand Rapids, Minnesota, United States, 55744
      • Fairview Grand Itasca Clinic & Hospital
    • Hibbing, Minnesota, United States, 55746
      • Fairview Range Medical Center
    • Mankato, Minnesota, United States, 56001
      • Mayo Clinic Cancer System
    • Minneapolis, Minnesota, United States, 55415
      • Epidemiology Clinical Research Center
    • Monticello, Minnesota, United States, 55362
      • Monticello Cancer Center
    • Park Rapids, Minnesota, United States, 56470
      • Essentia Health - Park Rapids Clinic
    • Princeton, Minnesota, United States, 55371
      • Fairview Northland Medical Center
    • Virginia, Minnesota, United States, 55792
      • Essentia Health -Virgina Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Colorectal adenoma diagnosis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Anna Prizment, PhD, MPH, University of Minnesota, Epidemiology and Community Health

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: microbiome; gut; ginger; gingerol
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: SPH-2017-25928; Anna-CPRC-TBD (Other Identifier: UMN Clinical Protocol Review Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No