An interventional study of Ginger extract and Placebo in Colorectal Adenoma, sponsored by University of Minnesota. Completed at 13 sites in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by University of Minnesota · Not applicable, Interventional, and Basic science
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:
Exclusion Criteria:
Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
Dietary Supplement: Ginger extract
Placebo, daily for 6 weeks, followed by 6 week washout.
Other: Placebo
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
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).
Time frame: 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
Time frame: Baseline to 6 weeks
Change in gut microbiome composition
Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.
Time frame: Baseline to 12 weeks
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Minnesota