None listed
Conditions
Brief summary
Antimicrobial resistance- AMR (in particular antibiotic resistance) has been identified as one of the biggest threats to global health by the World Health Organization. If no sustained action is taken now, >10 million people could die each year by 2050 directly due to antimicrobial resistance (O'Neil, 2016). Nutritional interventions have been identified through literature review to have potential to combat against AMR. The most promising strategy is the popular use of probiotics (“live microorganisms which when administered in adequate amounts confer a health benefit on the host”) to restore and boost the beneficial microbes in our bodies. Another nutritional strategy for modulating the microbiota is consumption of dietary fibre and prebiotics that can be metabolized by microbes in the gastrointestinal tract. The functional food group of fermented foods, defined as foods or beverages produced through controlled microbial growth, and the conversion of food components through enzymatic action is another potential candidate nutrition strategy for combating AMR. Another food group that shows promise includes the polyphenol-rich food, polyphenols are a group of plant metabolites with potent antioxidant properties, which protect against various chronic diseases induced by oxidative stress. Lastly, interest in the use of trace metals as antimicrobial agents such as zinc, selenium, copper, iron, manganese, and other trace metals are increasing. Trace metals are naturally occurring essential microelements recommended for daily intake. These minerals are present in a wide range of foods in addition to their presence in nutritional supplements. The aim of the proposed project is to conduct a small pilot proof-of-concept human study to investigate the use of combination nutritional interventions to reduce AMR. In this pilot study, we will assess whether the natural nutritional interventions enhance gut microbial diversity and profiles, reducing resistant bacteria in the gut as well as enhancing immune functions in humans. The results of this study will provide proof-of-concept evidence to support the potential role of these nutritional interventions in combatting against AMR, and therefore whether it could be implemented as an adjunct nutritional therapy for AMR.
Interventions
60 Participants (4 groups of n=15) will be provided with one of the following interventions to consume once daily for 8 weeks (56 ± 2 days). All products are commercially available.
Intervention (#1): A synbiotic (Caruso’s Once Daily Probiotics - as in the control) + peppermint oil (NOW Foods Peppermint Gels). Each capsule contains 0.4ml of peppermint oil.
Intervention (#2): A synbiotic (Caruso’s Once Daily Probiotics – as in the control) + micronutrient (Health Aid Multi Minerals)
Health Ai
60 Participants (4 groups of n=15) will be provided with one of the following interventions to consume once daily for 8 weeks (56 ± 2 days). All products are commercially available. Intervention (#1): A synbiotic (Caruso’s Once Daily Probiotics - as in the control) + peppermint oil (NOW Foods Peppermint Gels). Each capsule contains 0.4ml of peppermint oil. Intervention (#2): A synbiotic (Caruso’s Once Daily Probiotics – as in the control) + micronutrient (Health Aid Multi Minerals) Health Aid Multi Minerals – each tablet contain (average): Vitamin D (400 iu): 10µg Calcium: 163mg Iron: 3.3mg Zinc: 3mg Iodine:58µg Copper: 0.5mg Manganese: 1.6mg Chromium: 25µg Molybdenum: 400µg L-Glutamic Acid: 25mg Betaine Hydrochloride: 25mg Intervention (#3): A synbiotic (Caruso’s Once Daily Probiotics – as in the control) + polyphenol (California Gold Nutrition, Trans-Resveratrol) California Gold Nutrition, Trans-Resveratrol- each tablet contains: Trans-Resveratrol (as Veri-teTM 98% Trans-Resveratrol) 200mg Other ingredients – modified cellulose, microcrystalline, rice extract and rice hull. These products are commercially available and can be purchased in supermarkets. For this study, these nutritional supplements will be supplied to the participants to consume for the duration of the study period. All interventions will be consumed in the form of capsules/tablets. Adherence to the intervention will be monitored by a weekly email sent to the participant for them to complete and also a paper product checklist they will complete at home and bring to the final appointment. The participant will also return all packaging at their final visit.
Sponsors
CSIRO
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to provide written Informed Consent 2. Able to access own email inbox 3. Be able to attend the CSIRO nutrition clinic for around 2.5 hours on two occasions across an eight-week period. 4. Willing to consume their regular habitual diet throughout the study period 5. Adults (males and females) 6. =18-<66 years of age at clinic screen 7. BMI of =18.5 - =35 kg/m2 8. An episode of acute infection (any type) requiring at least one course of antibiotics in the past 3 months* *Self-reported, no clinical testing will be performed
Exclusion criteria
1. Health conditions* that could affect gut and immune health such as gastrointestinal diseases [including, but not limited to diverticulitis, ulcerative colitis, Crohn’s disease, or coeliac disease, colostomy], type 1 or type 2 diabetes, cancer, renal or liver diseases in the last 12 months. 2. Immunocompromised (diagnosed with HIV, AIDS) or having an organ or bone marrow transplant in the last 12 months. 3. Gastrointestinal symptoms* (i.e. pain, reflux, diarrhea, or constipation), surgeries* (i.e. bariatric surgery such as gastric banding) or use of medications* (i.e. appetite suppressants (orlistat, phentermine and liraglutide), steroids (corticosteroids, progestogen, androgens and estrogens) known to potentially affect energy intake, appetite, or gastrointestinal motor function 4. Have a biliary disorder 5. Currently taking medication for hypertension and or high cholesterol 6. Currently taking supplements (probiotics, prebiotics, fibre, micronutrients, multivitamins, essential oils) or functional foods (fermented food, polyphenols) in the previous 4 weeks of Visit 1. 7. Known food allergies or intolerances to the study intervention products 8. Pregnant and/or lactating women 9. Current smoker (or history of smoking within the last six months) 10. History of or known presence of alcohol abuse or illicit drug use* 11. Received an investigational drug within 28 days prior to Visit 1 that in the opinion of the investigator may affect the applicant’s ability to participate in the study or the study results *Self-reported, no clinical testing will be performed
Outcome results
None listed