The Effect of Ginger on the Gut Bacteria of Healthy Adults

Phase 1

Completed

• Conditions: Gastrointestinal dysfunction; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12620000302954
• Lead Sponsor: Bond University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Study Completion: 2021-05-31
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

No known medical condition or syndrome
- No routine drug/medication use and/or willing to have no drugs/medications for 3 weeks
- No antibiotic use within the previous six months
- No illness or injury in the previous two weeks (e.g. common cold, food poisoning, bone fracture)
- Not pregnant or breastfeeding, and do not suspect they may be pregnant
- If woman of childbearing potential, use of non-hormonal contraception, sterile partner or abstinence
- No use of hormonal contraception in the previous two weeks, and no use of other contraception (e.g. implanon, injection, IUS) in the previous three months (Please note: Participants will not be encouraged to cease hormonal contraception to enrol in this study. If participants have ceased hormonal contraception in the specified time frames for
reasons other than to enrol in this study, then they will be deemed eligible in regards to this criteria).
- No known biochemistry abnormalities during the previous six months
- Gastrointestinal symptom rating scale (GSRS) score below 15 (no symptoms of nausea, reflux, indigestion, diarrhoea,
constipation, or gastrointestinal pain)
- No history of ingestion of probiotic supplements of any amount (e.g. capsules, powders) in the previous two weeks and
no history of any probiotic-containing foods (e.g. probiotic drinks, fortified yoghurts, fermented foods) in the previous
week, and willing to have none for three weeks.
- Willing to have no ginger-containing supplements or ingestion of any amount of fresh, dried, or liquid ginger for three
weeks
- Non-habitual tobacco user (daily tobacco user of any amount) and willing to use no tobacco products for three weeks
- Regular coffee/tea consumption of less than 5 per day, and willing to have 2 or less coffees/teas per day for three weeks.
- Non-habitual alcohol drinker (2 or less standard alcohol drinks per day) and willing to have 2 or less standard alcohol drinks per day.
for 3 weeks
- Willing to have no artificial sweeteners or artificial-sweetener containing foods and beverages for 3 weeks

Exclusion Criteria

- No written informed consent
- Non-English speaking persons or people with cognitive impairment which impacts on ability to provide informed consent or understand multiple-step instructions
- History of adverse reactions to ginger or ginger-containing products
- Swallowing difficulties preventing supplement ingestion
- Any type of dietary restriction currently or within the past two weeks
- Any other reason the investigator deems the participant to be unsuitable to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beta diversity of gastrointestinal microbiota (quantities of bacteria species and strains) as measured by 16S rRNA sequencing of stool swab samples. [Baseline (prior to supplement consumption) and on day 13 or 14 of supplementation consumption.]

Secondary Outcome Measures

Name	Time	Method
Bowel habits (number and time of day of bowel movements) as measured by daily bowel habit diary.[Daily during the one-week run-in period and daily during the 14-day supplementation period.];Depression, anxiety and stress as measured by the DASS-21 survey.[At baseline prior to supplementation and on day 14 of supplementation.];Fatigue as measured by the MFI survey.[At baseline prior to supplementation and on day 14 of supplementation.];Quality of Life as measured by the Euro Quality of Life (EQ5D-5L) survey.[At baseline prior to supplementation and on day 14 of supplementation.];Adverse events (e.g. reflux, indigestion, abdominal discomfort, gastrointestinal upsets, uncontrollable bleeding) as measured by self-reported daily dairy.[Daily during one-week run-in period and daily during the 14 day supplementation period.];Consistency of bowel movements using the Bristol Stool Chart.[Daily during the one week run in period and daily during the 14-day supplementation period.]