The Effect of Ginger on the Gut Bacteria of Healthy Adults

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: Participants of the intervention group will orally consume four standardised ginger root powder (Zingiber Officinale) extract capsules per day for 14 days. Total active ingredients consumed per day will be 64mg of gingerols and 20mg of shogaols. Two capsules will be consumed in the morning and two in the evening. Participants will be reminded to take the capsules via a text message every second day. Participants will record their adherence to the intervention whilst completing an online daily compliance and stool diary. In addition, following completion of the two‐week intervention period, capsule bottles will be returned to the researcher and the number of capsules remaining in the bottle will be used to determine compliance. CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Gastrointestinal dysfunction; ; Gastrointestinal dysfunction PRIMARY OUTCOME: 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: 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.] 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.] 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.] 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.] 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
Epistemonikos ID: aa5062dbb9d32245a96f96b39895760be0c9aab8
First added on: Aug 24, 2024