Impact of Probiotics on Gut Microflora and the Metabolism of Orange Juice Flavonoids

Not Applicable

Active, not recruiting

• Conditions: The impact of microencapsulated probiotics on the gut microflora, and on the absorption and metabolism of ingested orange juice flavanones in healthy individuals.; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12612000762853
• Lead Sponsor: CSIRO Preventative Health National Research Flagship – Colorectal Cancer Theme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of the flavanone catabolites in urine prior to, and after consumption of the orange juice, and before and after the course of microencapsulated probiotics.[Measured in urine samples collected 24 hours prior to and 24 hours post each of the three 2-hour clinic attendances.]

Secondary Outcome Measures

Name	Time	Method
Quantitative evaluation of the effective delivery of the microencapsulated probiotics to and colonisation of the large intestine by examination of the coliforms present and abundance of the specific probiotic species delivered in faecal material collected prior to, during, and at the end of a 3 week course of the microencapsulated probiotic. <br>Genotoxicity analysis of the faecal water prior to, and after consumption of the orange juice, and before and after the course of microencapsulated probiotics.[Measured in faecal samples collected prior to the long ingestion phase (25 day duration) of the probiotic supplement and also at weekly intervals for the 4 weeks post the long ingestion phase.]