Our client wanted to develop a product based on an oil extract with possible anti inflammatory properties. The client commissioned Trinity to conduct an invitro study to determine the efficacy of the oil alone and the oil with additives and compare these with a known anti-inflammatory preparation.
The client and Trinity’s Director of Research had a series of conversations to clarify
• what knowledge the client wanted at the end of the research,
• the most appropriate research approach and the nature of the samples to be tested,
• the most appropriate commercial products to use as comparators and
• the sample concentrations to be used.
Once agreement on these points was made, Trinity prepared a detailed study plan. The plan provided full details on:
1. Test materials
2. Sample preparation and extraction
3. Experimental design
4. Statistical methods
5. Record maintenance and archiving
6. Reporting
After client sign off of the study plan, Trinity conducted an invitro programme to measure the inhibition of neutrophil activation by the samples by quantifying the secretion of the inflammatory markers, tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). The efficacy of the samples was referenced to known anti-inflammatory markers and an unsupplemented group.
Following the study a detailed report was prepared. Included in it were
1. The experimental study details
2. Results, discussion and interpretation
3. The data in tabulated and graphical format
4. A summary of findings.
5. References
The findings were that the basic product had good anti-inflammatory effects and one of the samples, the product plus an additive was an extremely potent anti-inflammatory and completely inhibited IL-6 at all concentrations tested. It also completely inhibited TNF-α at all but the lowest concentrations.
This study provided the client with independent scientific verification of the anti-inflammatory benefits of their product and suggested a future product development path.