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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

13/10/2024

Date data sharing statement initially provided

5/03/2020

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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

Beta diversity of gastrointestinal microbiota (quantities of bacteria species and strains) as measured by 16S rRNA sequencing of stool swab samples.

Timepoint [1]

Baseline (prior to supplement consumption) and on day 13 or 14 of supplementation consumption.

Secondary outcome [1]

Bowel habits (number and time of day of bowel movements) as measured by daily bowel habit diary.

Timepoint [1]

Daily during the one-week run-in period and daily during the 14-day supplementation period.

Secondary outcome [2]

Depression, anxiety and stress as measured by the DASS-21 survey.

Timepoint [2]

At baseline prior to supplementation and on day 14 of supplementation.

Secondary outcome [3]

Fatigue as measured by the MFI survey.

Timepoint [3]

At baseline prior to supplementation and on day 14 of supplementation.

Secondary outcome [4]

Quality of Life as measured by the Euro Quality of Life (EQ5D-5L) survey.

Timepoint [4]

At baseline prior to supplementation and on day 14 of supplementation.

Secondary outcome [5]

Adverse events (e.g. reflux, indigestion, abdominal discomfort, gastrointestinal upsets, uncontrollable bleeding) as measured by self-reported daily dairy.

Timepoint [5]

Daily during one-week run-in period and daily during the 14 day supplementation period.

Secondary outcome [6]

Consistency of bowel movements using the Bristol Stool Chart.

Timepoint [6]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Bond University

Address [1]

14 University Drive, Robina QLD 4226

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

14 University Drive, Robina QLD 4226

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

14 University Drive, Robina QLD 4226

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/02/2020

Approval date [1]

28/02/2020

Ethics approval number [1]

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

Ms Megan Crichton

Address

Bond University
14 University Drive, Robina QLD 4226

Country

Australia

Phone

+610755951111

Fax

Megan.crichton@qut.edu.au

Contact person for public queries

Name

Megan Crichton

Address

Bond University
14 University Drive, Robina QLD 4226

Country

Australia

Phone

+610755951111

Fax

Megan.crichton@qut.edu.au

Contact person for scientific queries

Name

Megan Crichton

Address

Bond University
14 University Drive, Robina QLD 4226

Country

Australia

Phone

+610755951111

Fax

Megan.crichton@qut.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Effect of Ginger Root Powder on Gastrointestinal Bacteria Composition, Gastrointestinal Symptoms, Mental Health, Fatigue, and Quality of Life: A Double-Blind Placebo-Controlled Trial.	2023	https://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.

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Documents added manually

Documents added automatically