This study was led to validate the concept of a solid cereal base which could be eaten even by edentulous persons, with a low masticatory ability. The cookies texture was finalized in a clinical trial on 60 patients, in the University of Nice Hospital.
Initial cookies used in this study were not yet enriched in proteins. Their formulation had only 7 % of the weight in protein contributed by flour and egg whites, as in an ordinary biscuit. This first lots of cookies was made in the Central Food Production Unit of Nice University Hospital. The protocol was approved by the local ethic committee and all the patients included gave their written informed consent.
The patients were recruited in the infectious diseases ward and in the long term geriatric ward of Nice University Hospital. Consumption of other oral nutritional supplements (ONS) was not a criterion of exclusion. The researchers performed saliva assessments (sialometry) and performed a basic dental examination. They recorded patients’ oral complaints and their masticatory ability. Masticatory ability is the number of couples of opposing teeth allowing for the chewing of a solid food. It ranges from 100 % for a fully dentate person to 0 % for an edentulous person. In the study, the masticatory coefficient varied from 0 to 100 %. The correlations between the time necessary to chew and swallow a cookie and the quantitative parameters was measured with the coefficient of Spearman (SAS 6.0, SAS Institute, Cary, NC).
The clinical study was realized from November, 2005 till January, 2006. For 60 patients, 27 patients presented a decrease of saliva secretion objectified by a reduced salivary stimulated flow rate (SSFR) lower than 1.5 ml/min. There was a link between hypo-salivation and difficulties eating (area under the curve = 0.941). The average time to chew and swallow cookies was longer in case of hypo-salivation (51.9 versus 30.7, p < 0.001), but not in cases of dental pain (39.5 versus 39.9, p < 0.96). Similarly, the masticatory ability had no effect on the time necessary to chew and swallow cookies (SSFR < 1 ml/min, area under the curve = 0.921; SSFR < 1.5 ml/min, area under the curve = 0.950).
Thanks to their innovative texture, these cookies could be eaten regardless of the masticatory ability of the patient, even fully or partially edentulous patients. Dental pain did not prevent the patients from eating them.
This preliminary clinical study yielded a cereal base which was then enriched in protein and in energy to create Protibis cookies. It is an alternative to drinks and creams usually used as ONS. High protein and high energy Protibis cookies were thus designed by doctors specialized in geriatrics and in nutrition, dietitians and dental surgeons to fight against the malnutrition of diseased and elderly people. Protibis cookies have 22 % of their weight in protein, with 22.2 g of protein and 468 kcal for 100g.
Protibis cookies have a three-level innovative texture (crunched, dipped or softened). They can even be eaten by people having a bad oral condition. They crumble easily between toothless jaws. In case of masticatory muscles fatigue or oral dryness, Protibis cookies can be dipped into a warm or cold drink without splitting too quickly. For those patients with swallowing disorders, they can be crumbled and softened in a drink.