None listed
Conditions
Brief summary
Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels compared to all other varieties of plums. We hypothesize that antioxidant rich QGP may lead to decreased platelet and clotting activity, reducing inflammation and improving lipid profile by influencing fat metabolism in normal healthy population as well as under increased oxidative stress conditions. The aims of the present double blind crossover interventional study are to compare and examine effectiveness of the 4 weeks supplementation of Queen Garnet Plum with commercial Bickford prune juice and a colour and sugar matched placebo on platelet and haemostatic function as well as inflammation markers and lipid profile in normal healthy population. We wish to prove our hypothesis that due to high antioxidant (anthocyanin) content these fruits may be instrumental in preventing cardiovascular disorders by attenuating platelet and haemostatic activity. For the first protocol of the study, 20 volunteers will be screened for recruitment to the study based on inclusion and exclusion criteria. Each participant will undertake 3 oral supplementation treatments for 4 weeks each with a washout period of two weeks between each treatment. A pre and post treatment fasting blood and urine sample will be collected to evaluate the efficacy of each treatment and comparison between placebo and two types of plums. Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, lipid profile, uric acid and full blood + urine antioxidant levels with specific polyphenol quantitative screen. Second protocol will be similar to first protocol but with only 2 oral supplementation treatments of 4 weeks each with one 2 week washout period between them. The participants will be tested for VO2max by physician trained in exercise science prior to starting this protocol of the trial. A fasting blood and urine sample will be collected from each participant both pre and post induced oxidative stress by 45 min – 60 min exercise at 70% of maximal aerobic power (VO2max) before and after 4 weeks consumption of QGP and placebo. Testing protocol will be similar but including some specialised testing of platelet surface markers and thrombolytic pathways to examine the mechanistic pathways affected by the plum supplementation in reducing the thrombotic risk factors.
Interventions
Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels (anthocyanins) compared to all other varieties of plums.
Arm 1:
In the first protocol of this double blind crossover study we will compare the effect of 4 weeks of oral supplementation with 200 ml per day of QGP juice with commercially available 2
Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels (anthocyanins) compared to all other varieties of plums. Arm 1: In the first protocol of this double blind crossover study we will compare the effect of 4 weeks of oral supplementation with 200 ml per day of QGP juice with commercially available 200 ml/day for 4 weeks Bickford Prune juice and a 200ml/day for 4 weeks placebo in 20 normal healthy male and female participants between ages of 18 to 65 years. There will be two weeks washout period between each treatment. The blood and urine sample will be collected pre and post each supplementation period. Arm 2: After 2 weeks of no treatment ( washout period) the articipants will start second protocol of the trial.. In the second protocol of this same study all the participants from first protocol will be invited to continue after 2 weeks washout period, however incase there is any participant who does not want to continue, will be allowed to stop at that stage and the new participants will be recruited to replace those who withdraw to maintain total number of 20 normal healthy male and female volunteers for the second protocol. All the participants in this second protocol will be asked to repeat the same intervention as in first protocol that is 200ml/day over 4 weeks of QGP and Placebo treatment with a two weeks washout period between the two treatmemnts. However this time the participants will provide blood and urine sample both before and after 45-60 minutes of monitored acute exercise undertaken by cycling in laboratory at 70% of their maximal aerobic power (VO2max) at the start and finish of the supplementation. A doctor will determine the duration of exercise based on participants capability and fitness for each participant by conducting VO2max test on each volunteer before the supplementation for second protocol starts. Each participant will carry out the exercise 4 times over the complete trial period. Prior to first supplementation (baseline exercise will be undertaken on day 1 of protocol 2 immediately after the fasting blood and urine sample collection with second sample collected within 30 minutes of completing the exercise. Second bout of exercise will be conducted on day 29 of the second protocol with blood and urine sample collected before and after the exercise again. After 2 weeks washout period the third bout of exercise will be undertaken by participants on day 44 before starting second treatment and again the final and 4th bout of exercise regimen will be on day 72 that is 4 weeks after final supplementation period of second protocol.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Normal healthy non smokers with no history of heart disease or bleeding disorder. Volunteers not on any special diet or medication. Health and food frequency questionnaire and baseline Full Blood Examination (all parameters must be within normal healthy population reference range) will be examined to confirm health status.
Exclusion criteria
Excessive bleeding tendency History of problem with venepuncture Anti-Coagulant therapy Recent GI bleed History of Heart and Liver Disease Anti-inflammatory Drugs affecting platelets ( in particular aspirin) Regular Multivitamin intake Plt <125 & >450
Outcome results
None listed