None listed
Conditions
Brief summary
This study will be conducted in healthy individuals to investigate the impact of a co-delivery versus a 3 week course of microencapsulated probiotic (Bifidobacteria) on the degradation and absorption of orange juice flavanones. This will be assessed by: a) Quantitative evaluation of the effective delivery of microencapsulated (MicroMAX Pro (Registered Trademark) – milk protein-sugar-carbohydrate powder) probiotic (Bifido bacteria) by faecal sample examination. b) Analysis of the phenolic acids and flavanone glucuronide and sulphate metabolites in urine and faecal water using high-level analytical techniques (GC-MS and HPLC-MS-MS). This information will provide insights into the impact of a microencapsulated probiotic on the gut microflora, and on the absorption and metabolism of ingested orange juice flavanones. The specific aims of this investigation are: 1. To investigate co-delivery of probiotic with orange juice on the metabolism amnd absorption of flavanones in the large intestine 2. To investigate the impact of a 3 week course of probiotic on the metabolism and absorption of flavanones in the large intestine.
Interventions
24 participants will be recruited.
There will be three intervention phases.
72 hours prior to the first probiotic intervention, participants will commence a 4-day duration of a special low polyphenol diet (avoiding fruits and vegetables, including those in prepared dishes, and juices thereof, tea coffee, drinking chocolate, alcohol (especially red wine, beer and apple cider)), chocolate and chocolate products, cereals, grains, wholemeal bread, spices (such as curry) and herbs.
For 24 hours
24 participants will be recruited. There will be three intervention phases. 72 hours prior to the first probiotic intervention, participants will commence a 4-day duration of a special low polyphenol diet (avoiding fruits and vegetables, including those in prepared dishes, and juices thereof, tea coffee, drinking chocolate, alcohol (especially red wine, beer and apple cider)), chocolate and chocolate products, cereals, grains, wholemeal bread, spices (such as curry) and herbs. For 24 hours prior to the first probiotic intervention participants will collect a full urine save. Participants will fast (water allowed as required) from 10 pm the evening prior to their attendance at the clinical research unit. On that first intervention morning, participants will attend the clinic in a fasted state and complete a 24 hour urine save upon arrival. Participants will then consume a 350 ml serving of orange juice plus a single dose (up to 5 g) of probiotic in an encapsulated format (MicroMAX Pro (Registered Trademark)) and commence collecting urine for a period of 2 hours while remaining in the clinic. The 5 g dose of encapsualted probiotic is equivalent to a daily dose of probiotic containing between 1 billion and 10 billion colony forming units, which is the amount recommended by most authories. After the 2 hour visit is complete, participants will be free to leave, but will still follow the low polyphenol diet until 8 am the following morning. Participants will also be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours. Following the first intervention visit and until the completion of the study, participants will be instructed to avoid probiotic-enriched foods. After a period of ~26 days volunteers will again commence a 4 day low-polyphenol diet and will also collect a full 24 hour urine save prior to attending the clinic. In addition, faecal samples will be collected for a full 48 hour period prior to the intervention. Participants will again arrive at the clinic in a fasted state (from 10 pm the evening prior), when they will complete their 24 hour urine collection and then consume a 350 ml serve of orange juice. After the 2 hour visit is complete, participants will be free to leave, but will still follow the low polyphenol diet until 8 am the following morning. Participants will also be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours. A 24 day supply of probiotic supplements (up to 5g per day) will be supplied to each volunteer who will be instructed to consume one supplement per day for the next 24 days. Participants will collect full 48 hour faecal saves at the end of each week for the following 4 weeks – providing a total of five 48 hour faecal collections for the study. After 21 days on the probiotic supplement (up to 5g per day), volunteers will continue to take the supplement and commence a four day low-polyphenol diet. They will also collect a full 24 hour urine save prior to their third and final clinic visit for the third intervention. Participants will arrive at the clinic in a fasted state (from 10 pm the evening prior and having had no supplement that morning), when they will complete their 24 hour urine collection and then consume a 350 ml serve of flavanone-enriched orange juice plus a single dose of probiotic (up to 5g). After the 2 hour visit is complete, participants will be free to leave, but will be instructed to continue to collect full urine saves for the following 22 hours into collection bottles labelled as 2-5 hours; 5-10 hours and 10-24 hours. Participants will continue to follow the low polyphenol diet while collecting the urine save until 8 am the following morning. All participants will record their supplement intake on a daily checklist and will also record any deviations from the 4 day low-polyphenol diet and any accidental intake of probiotic enriched foods.
Sponsors
CSIRO Preventative Health National Research Flagship – Colorectal Cancer Theme
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and females aged between 18-70 years. 2. Normal dietary habits (no medically prescribed diet, not taking vitamin, probiotic, prebiotic, or antioxidant supplements, no slimming diet, and no vegan or macrobiotic diet). 3. Body Mass Index > 18 kg/m2 < 35 kg/m2 (calculation: Body Mass Index = weight in kg / height2 in m2). 4. Apparently healthy: no reported current or previous metabolic diseases, gastrointestinal disorders, renal or cardiovascular disease. 5. Person having given their specific consent in writing.
Exclusion criteria
1. Regular use of supplements containing probiotics within two months prior to the start of the study. 2. Regular consumption of foods supplemented with probiotics such as some breads and milk products within 2 months prior to the start of the study. 3. Current medical treatment or medication that may interfere with the study (this will be assessed from the medical questionnaire). 4. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions. 5. High alcohol consumption (> 21 standard drinks/week). 6. Reported participation in another biomedical trial 3 months before the start of the study or during the study. 7. Food allergies or intolerances (dairy, lactose, peanuts, shellfish, etc). 8. Recent history (within 12 months) of substance abuse including alcohol abuse. 9. Intolerance to probiotics or orange juice. 10. Pregnant. 11. Smokers.
Outcome results
None listed