
Many of the same approaches applied by CRO to accelerate the early clinical development of pharmaceuticals and biopharmaceuticals are of benefit to the study of nutritional and other non-drug products. With increasing emphasis on the need to scientifically support health claims, there is an increasing need to undertake rigorous and controlled clinical studies. With the anticipated benefit of nutritional and other non-drug products typically being very “subtle”, there is also a need to employ highly sensitive diagnostics to discern benefits from background noise and thus avoid the need for prohibitively large sample sizes.
CRO uses its access to advanced diagnostic technologies and biomarker expertise to do just that.
For example, we are regularly working with medical immunologists to analyze biological markers of innate immunity. These provide an objective supplement to observational assessment of a nutritional product’s benefits on immune function.
By collaborating with the Charité Medical Immunology Institute, Charité Research Organisation is able to undertake studies incorporating highly sensitive immune system markers. Use of such highly sensitive measure can provide an objective assessment of he impact of a product on immunity in addition to observational measures such as the use of questionnaires to track incidence and severity of upper respiratory tract infections. For example, a nutritional intervention study in 200 healthy volunteers to explore objective and quantifiable benefits to immune system and impact on innate immunity.
Charité Research Organisation is designing and undertaking studies evaluating the effects of products on markers of cardiovascular health. For example, CRO is able to use two different methodologies for evaluating arterial stiffness (PWL, AIx): ArterioGraph and SpyghmoCor. Arterial stiffness may be an effective marker of cardiovascular health and can be assessed following acute and chronic effects of an intervention. Ambulatory blood pressure monitoring is also regularly used to assess impact of an intervention on blood pressure over a period of time, which may be a considerably more reliable marker than static office blood pressure assessments. In collaboration with the Charité Cardiology Department, CRO is also able to offer assessments of flow-mediated dilation as a marker of endothelial function.
A range of studies can be designed and implemented to assess the effect of a product on appetite and weight. For example, this could include typical studies to assess calorie consumption pre- and post- intervention. If dietary advice is required, then CRO can provide access to highly experience dieticians who can develop diets to complement studies.
Close collaboration with Charité Dermatology facilitates the investigation of many subtle parameters of skin health and aging. For example, profilometry can be used to assess the effect of a product on skin wrinkling. Other measures, such as colormetry can be used to assess changes in skin. Techniques, such as applying UV irradiation and determining the MED can be employed to look for signs of changes in skin health before and following interventions.
The impact of a product on digestive health can be investigated in a number of ways. For instance, use of simple validated questionnaires can help in determining the influence of a product on stool frequency. Further use of questionnaire – possibly accompanied by evaluation of select biomarkers – can be used to determine the influence of a product on incidence of gastrointestinal infections. Collaboration with Charité Gastroenterology Department makes possible the implementation of assessments of parameters such as gastric emptying and transit time.
By collaborating with Charité Radiology Department, Charité Research Organisation is able to undertake studies evaluating subtle changes in bone and skeletal health. Collaboration with Charité makes possible the use of DXA scanning to look at changes in bone and fat density and distribution pre- and post- intervention.
Charité Research Organisation can use technologies frequently deployed in respiratory studies to help assess energy and physical performance. This can include use of exercise bikes and treadmills to assess effects on exercise capacity along with assessments of oxygen intake and lung capacity.
By collaborating with neuroscience departments, Charité Research Organisation is able to design and implement studies to investigate the effect of a product on cognitive performance. At a basic level this could include evaluation of performance in paper & pencil tests (or computerized equivalents). At a more advanced level, it could incorporate the use of techniques such as f-MRI.