Bioavailability Study of Different Dietary Antioxidants in Volunteers
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Sampling method: Non-Probability Sample
Study population: 
        Residents of Cambridgeshire
      
Biospecimen description: 
      serum