Ginger and Gut Microbiome (GINGER)

Not Applicable

Completed

• Conditions: Colorectal Adenoma
• Interventions: Dietary Supplement: Ginger extract; Other: Placebo

• Registration Number: NCT03268655
• Lead Sponsor: University of Minnesota

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..

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 Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Start: 2018-11-14
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Colorectal adenoma diagnosis

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginger extract	Ginger extract	Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
Placebo	Placebo	Placebo, daily for 6 weeks, followed by 6 week washout.

Primary Outcome Measures

Name	Time	Method
Urine inflammatory biomarker	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
Composition of the gut microbiome	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).

Secondary Outcome Measures

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

Trial Locations

Locations (12)

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

Monticello Cancer Center; 🇺🇸 Monticello, Minnesota, United States

Mayo Clinic Cancer Center; 🇺🇸 Austin, Minnesota, United States

Essentia Health - Deer River; 🇺🇸 Deer River, Minnesota, United States

Fairview Northland Medical Center; 🇺🇸 Princeton, Minnesota, United States

Essentia Health - Park Rapids Clinic; 🇺🇸 Park Rapids, Minnesota, United States

Epidemiology Clinical Research Center; 🇺🇸 Minneapolis, Minnesota, United States

Essentia Health -Virgina Clinic; 🇺🇸 Virginia, Minnesota, United States