Ginger and Gut Microbiome (GINGER)



Status:Recruiting
Healthy:No
Age Range:50 - 75
Updated:3/8/2019
Start Date:November 14, 2018
End Date:May 29, 2020
Contact:Anna Prizment, PhD, MPH
Email:prizm001@umn.edu
Phone:612-626-0250

Use our guide to learn which trials are right for you!

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..

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.

Inclusion Criteria:

- Colorectal adenoma diagnosis

Exclusion Criteria:

- Allergy or sensitivity to ginger

- Active cancer

- Unstable medical condition

- Unstable diet or weight
We found this trial at
5
sites
Albert Lea, Minnesota 56007
Phone: 612-624-2620
?
mi
from
Albert Lea, MN
Click here to add this to my saved trials
Austin, Minnesota 55912
Phone: 612-624-2620
?
mi
from
Austin, MN
Click here to add this to my saved trials
Mankato, Minnesota 56001
Phone: 612-624-2620
?
mi
from
Mankato, MN
Click here to add this to my saved trials
1100 South Washington Avenue
Minneapolis, Minnesota 55415
Phone: 612-626-0250
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Monticello, Minnesota 55362
Phone: 612-624-2620
?
mi
from
Monticello, MN
Click here to add this to my saved trials