Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000302954
Ethics application status
Approved
Date submitted
10/02/2020
Date registered
5/03/2020
Date last updated
2/12/2021
Date data sharing statement initially provided
5/03/2020
Date results information initially provided
23/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Ginger on the Gut Bacteria of Healthy Adults
Scientific title
The Effect of Ginger (Zingiber Officinale) on the Gut Microbiota of Healthy Adults
Secondary ID [1] 300419 0
Nil
Universal Trial Number (UTN)
Trial acronym
The GINGer And the GUT Microbiota (GINGA GUT) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal dysfunction 316079 0
Condition category
Condition code
Diet and Nutrition 314351 314351 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316714 0
Treatment: Other
Comparator / control treatment
Participants in the control group will orally consume four placebo capsules containing microcrystalline cellulose per day for 14 days. Total daily consumption of microcrystalline cellulose will be 800mg. Two capsules will be consumed in the morning and two in the evening.
Control group
Placebo

Outcomes
Primary outcome [1] 322801 0
Beta diversity of gastrointestinal microbiota (quantities of bacteria species and strains) as measured by 16S rRNA sequencing of stool swab samples.
Timepoint [1] 322801 0
Baseline (prior to supplement consumption) and on day 13 or 14 of supplementation consumption.
Secondary outcome [1] 379832 0
Bowel habits (number and time of day of bowel movements) as measured by daily bowel habit diary.
Timepoint [1] 379832 0
Daily during the one-week run-in period and daily during the 14-day supplementation period.
Secondary outcome [2] 379833 0
Depression, anxiety and stress as measured by the DASS-21 survey.
Timepoint [2] 379833 0
At baseline prior to supplementation and on day 14 of supplementation.
Secondary outcome [3] 379834 0
Fatigue as measured by the MFI survey.
Timepoint [3] 379834 0
At baseline prior to supplementation and on day 14 of supplementation.
Secondary outcome [4] 379835 0
Quality of Life as measured by the Euro Quality of Life (EQ5D-5L) survey.
Timepoint [4] 379835 0
At baseline prior to supplementation and on day 14 of supplementation.
Secondary outcome [5] 379836 0
Adverse events (e.g. reflux, indigestion, abdominal discomfort, gastrointestinal upsets, uncontrollable bleeding) as measured by self-reported daily dairy.
Timepoint [5] 379836 0
Daily during one-week run-in period and daily during the 14 day supplementation period.
Secondary outcome [6] 380771 0
Consistency of bowel movements using the Bristol Stool Chart.
Timepoint [6] 380771 0
Daily during the one week run in period and daily during the 14-day supplementation period.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/03/2020
Actual
1/04/2020
Date of last participant enrolment
Anticipated
12/05/2020
Actual
12/05/2020
Date of last data collection
Anticipated
31/12/2020
Actual
31/05/2021
Sample size
Target
50
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304841 0
University
Name [1] 304841 0
Bond University
Country [1] 304841 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 305261 0
None
Name [1] 305261 0
Address [1] 305261 0
Country [1] 305261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305251 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 305251 0
14 University Drive, Robina QLD 4226
Ethics committee country [1] 305251 0
Australia
Date submitted for ethics approval [1] 305251 0
06/02/2020
Approval date [1] 305251 0
28/02/2020
Ethics approval number [1] 305251 0
MC03293

Summary
Brief summary
Ginger has long been used in ancient medicine. Modern research has found ginger has many health benefits from relieving nausea and pain to lowering blood pressure. However, little is known about how and why. Studies on animals suggest that ginger may benefit health through its effect on the gut microbiota. Therefore, The GINGA GUT (GINGer And the GUT Microbiota) Study will be the first human trial to assess the effects of ginger supplementation on the gut microbiota and related health outcomes (bowel habits, depression, anxiety, stress, fatigue, quality of life and adverse events). Participants will be advised to follow a one-week run-in period to stablise diet and lifestyle factors (e.g. sleep, exercise, diet), followed by a 14-day supplementation period of either four ginger root or placebo supplements per day (two in the morning and two at night). Participants will take one stool swab sample prior to supplementation and one on the 13th or 14th day of supplementation. In addition, participants will answer numerous online surveys. It is hypothesised that ginger supplementation will be associated with increased quantities and diversity of gut bacteria species and strains.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99770 0
Ms Megan Crichton
Address 99770 0
Bond University
14 University Drive, Robina QLD 4226
Country 99770 0
Australia
Phone 99770 0
+610755951111
Fax 99770 0
Email 99770 0
[email protected]
Contact person for public queries
Name 99771 0
Ms Megan Crichton
Address 99771 0
Bond University
14 University Drive, Robina QLD 4226
Country 99771 0
Australia
Phone 99771 0
+610755951111
Fax 99771 0
Email 99771 0
[email protected]
Contact person for scientific queries
Name 99772 0
Ms Megan Crichton
Address 99772 0
Bond University
14 University Drive, Robina QLD 4226
Country 99772 0
Australia
Phone 99772 0
+610755951111
Fax 99772 0
Email 99772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval has not been sought for sharing raw data with others due to ethical concerns regarding obtaining re-identifiable information and the need to use participant data only for the intentions of this study. Other researchers requiring more information regarding data are encouraged to contact the Principle Investigator via email.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Ginger Root Powder on Gastrointestinal Bacteria Composition, Gastrointestinal Symptoms, Mental Health, Fatigue, and Quality of Life: A Double-Blind Placebo-Controlled Trial.2023https://dx.doi.org/10.1016/j.tjnut.2023.09.002
N.B. These documents automatically identified may not have been verified by the study sponsor.