None listed
Conditions
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.
Interventions
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 co
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.
Sponsors
Bond University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Outcome results
None listed