Clinical trial NCT03268655: Ginger and Gut Microbiome (GINGER)
Official title: Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenoma
Keywords: gingerol
microbiome
gut
ginger
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot. Double-blind placebo-controlled randomized trial
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Colorectal adenoma diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Composition of the gut microbiome
timeFrame: Baseline to 6 Weeks
measure: Urine inflammatory biomarker
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change in gut microbiome composition
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Austin
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health - Deer River
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health St Mary's - Detroit Lakes
state: Minnesota
city: Fosston
country: United States
facility: Essentia Health - Fosston Clinic
state: Minnesota
city: Grand Rapids
country: United States
facility: Fairview Grand Itasca Clinic & Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Medical Center
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Cancer System
state: Minnesota
city: Minneapolis
country: United States
facility: Epidemiology Clinical Research Center
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health - Park Rapids Clinic
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health -Virgina Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota, Epidemiology and Community Health
name: Anna Prizment, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: