General questions

We created and develop the tiny-TIM system to serve as a simplified, higher throughput, screening system for pharma and food companies to quickly and easily assess their APIs, ingredients, and novel foods.

The Tiny-TIM system has extensively and successfully validated for:

1. Protein digestibility and the bioaccessibility of amino acids in comparison to animal studies. (reference?)
2. The digestibility of carbohydrates, the bioaccessibility of glucose and fructose and the prediction of human plasma glucose concentrations in comparison to in vivo human glycaemic response curves (TIM-Carbo system). (reference?)
3. any others? In progress? (reference)

Since December 2013, six new Tiny-TIM systems have been installed. The systems have been tested extensively, followed by demonstrator studies for pharmaceutical studies (e.g. Verwei et al., 2016).

The microbiota in TIM-2 is a fair representation of that in humans. Using molecular tools (primarily DGGE) and plating on (s)elective plates we have shown that the composition of the microbiota does not change drastically when the samples are frozen quickly in liquid nitrogen and stored at -80 °C. After that, production of SCFAs as measured by gas chromatographic analysis was i) similar in multiple experiments, and ii) within physiological range. In addition, microbial activity as measured by the Api-zym enzymatic test-strip was very similar when TIM-2 was inoculated with fresh fecal samples or standardized frozen flora. In the case of the dogs, inoculation of the system with a fresh microbiota from the cecum, a fresh microbiota from feces, or a standardized microbiota from feces gave results in metabolite production that were highly correlated. Standardizations allows us to compare different test-products with the same starting microbiota (Venema et al., 2000).

We target the main bacterial species, more precisely it detects species to which the universal primers for PCT amplification are annealing.

We like to receive the test and reference compounds or formulations with a name or code, batch number, expiry date, storage conditions and safety data sheet. Besides this we like to receive some physical-chemical properties ; important for optimal set-up of experiments. If we also perform quantitative  analysis of the TIM samples, we like to receive the analytical method and lowest detection limit.

The results obtained with the TIM systems has been used in different reports and dossiers for the regulatory authorities. Regulatory authorities (e.g. FDA, EMA) are familiar with the TIM systems and the obtained results. The TIM Company as well as our clients discussed the set-up and results of TIM studies with the authorities. The results have been accepted as claim substantiation, but it is judged case by case.