Bioavailability Study of Different Dietary Antioxidants in Volunteers
Cardiovascular disease (CVD) continues to rank high among the leading causes of morbidity and mortality in adults worldwide. While diet and increased physical activity constitute the primary preventive health approach, the role of plant-based bioactive compounds has attracted much attention due to their unique cardio-protective benefits. Several epidemiological studies suggest that dietary patterns characterized by relatively high intake of fruits and vegetables are significantly associated with reduced risks of coronary heart disease and stroke.
Dietary bioactive compounds are potent anti-oxidants and anti-inflammatory agents, thereby counteracting oxidative damage and inflammation, which underlie the pathogenesis of CVD.
However, this area is really lacking of a good set of chemistry, bioavailability and efficacy data that is vital for nutrition researchers and doctors to emphasize their role in the prevention and treatment of clinical outcomes at different stage of CVD, and dissemination of this information to the general public.
Cambridge Theranostics has focused its efforts on developing products that can prevent the damaging oxidation of lipoproteins that leads to heart attacks and stroke, and on understanding the cause of that damage.
Extensive literature shows that Lycopene, Resveratrol and Soy Isoflavones are key ingredients in diets that long been known to reduce the risk of heart attack and stroke. However, they are normally poorly absorbed (not 'bioavailable'). The investigators unique production process presents Lycopene, Soy Isoflavones and Resveratrol to the body in a form that it can easily absorb and use.
The aim of the current study is to perform and compare bioavailability and absorption of those three different dietary antioxidants and their combinations. The study is funded by Cambridge Theranostics and will be done on healthy volunteers of various ages with 30 people in each product group. It will be conducted on the primacies of Cambridge Theranostics in Babraham Research Campus. And managed by the team of experienced professionals employed by Cambridge Theranostics. The study will last about 12 months including recruitment process, screening process, periodical blood samples collection and examination and statistical analyses at the end.
|Official Title:||Phase 1 Bioavailability Study of Different Dietary Antioxidants in Volunteers|
- AUCt - Area under the serum concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [t(last)] [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- AUC∞ - Area under the serum concentration-time curve from the time point [t=0] to infinity [∞] [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Cmax - Maximum serum concentration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- tmax - Time of maximum serum concentration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- t½ - Elimination half life [ Designated as safety issue: No ]
- AUC(last)-∞ - Difference between AUC∞and AUCt expressed as percentage value [ Designated as safety issue: No ]
- AUCt/AUC∞ - calculated as quotient of AUCt and AUC∞ [ Designated as safety issue: No ]
- f = Cmax/ AUCt (indication of rate of absorption) [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Mixed age and gender group of healthy volunteers for testing bio-availability of Lycopene containing supplement
Mixed age and gender group of healthy volunteers for testing bio-availability of Resveratrol containing supplement
Mixed age and gender group of healthy volunteers for testing bio-availability of Soy Isoflavones containing supplement
90 volunteers, who fulfill the inclusion criteria, do not meet any of the exclusion criteria, who have given written informed consent will be entered into the study. Lab assays and statistical analysis of the data will be performed on all plasma samples of those subjects who complete the study according to the study protocol or who partially complete the study with evaluable data. Subjects will be recruited from the subject pool of the CTL database.
The study will be performed as a daily for 8 weeks dose, open label, three arms study with 90 subjects.
The study will consist of three groups with one treatment period in each, with a wash-out period of 4 weeks prior the study.
All evaluable data are supposed to be used for the safety evaluation. The subjects will be taking products with a main meal daily. At certain time points (T0 - before study, T1 - 1 week of treatment, T2 - 2 weeks of treatment, T3 - 3 weeks of treatment, T4 - 4 weeks of treatment, T8 - 8 weeks of treatment) after an overnight fasting of about 11 hours the subjects will be invited to the lab for a blood sample collection. Blood samples for the analysis of serum concentrations of Lycopene, Resveatrol and Soy Isoflvones shall be drawn. Two aliquots of each sample will be prepared. One aliquot of each frozen serum sample will be shipped to analytical lab for bioanalysis of Lycopene, Resveatrol and Soy Isoflvones. Other aliquots will be retained at the CTL's lab. A total of 7 blood samples will be collected before and during product intake.
Analytical laboratory of Institute of Food Research, Norwich, will perform measurements of concentration of Lycopene, Resveatrol and Soy Isoflvones using a validated LC-MS/MS method. Calculations of the pharmacokinetic parameters and the assessment of bioavailability will be carried out for all products by CTL. The final report will include all aspects concerning the clinical part of the study, bioanalysis, statistics and discussion of obtained data as well as the legal and ethical requirements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199549
|Babraham Research Campus|
|Cambridge, Cambridgeshire, United Kingdom, CB22 3AT|