Nutrition and lifestyle counseling can play an important role in participant understanding of the protocol and adherence to protocol instructions. Counseling may include wash off instructions, food dairies, diet restrictions, weight maintenance, blood glucose, and diet management.
Participant recruitment and retention are key factors in successful study execution. ProSciento has the expertise to accommodate a variety of food preferences while maintaining highly standardized diets with consistent calories and macronutrient composition. Vegetarian, vegan, gluten restricted, dairy restricted accommodations, among others, can be made to support participant recruitment and retention. Food is locally sourced and delivered fresh daily.
Measuring changes in appetite and food intake is complex given the controlled nature of a clinical setting when compared to natural free-living conditions. What is eaten and where, and other environmental cues, all play a role in appetite research. ProSciento offers expertise in validated appetite studies to measure changes in satiety, calorie intake, gut hormones, and subtle changes in macronutrient intake.
Whether conducting out-patient or in-patient clinical trials, changes in body weight and diet have the potential to confound the effectiveness of a study drug. Standardized diets help mitigate lifestyle-induced changes.
Mixed meal tolerance tests, 7- point glucose profiles, and indirect calorimetry are just a few of the clinical assessments where highly standardized meals can be used to better understand the pharmacodynamic response to a study drug. It is recognized that food is an important factor impacting clinical outcomes and, therefore, it is controlled and used with precision and consistency.