The project has one main goal: to perform a clinical trial to compare the OBND with standard of care diet. The outcome of the clinical trial will be analyzed in the areas: medicine/odontology, sensory science, nursing, public health and health economics.
Study objectives:
* To assess if the consumption of the designated diet results in added medical/dental health outcome for the OBND in comparison to standard of care diet. The study is a randomized case control clinical trial.
* To perform cost-effectiveness analyses comparing costs and health benefits for the test and control diets with focus on individuals with type 2 diabetes mellitus and otherwise healthy individuals living in close relationship to those with diabetes.
* To assess consumer acceptance of the diet: (I) acceptance of the diets (questionnaire, focus groups and food diary), (II) acceptability of the diet in relation to taste of the diet, and the prospect of adopting the diet in everyday life, and (III) sensory analysis of identical dishes prepared according to the OBND and the standard of care diet.
Study design The study design is a randomized double-blinded clinical trial with four subgroups including 20 individuals per study group.
Test Group A: OBND, individuals diagnosed with type 2 diabetes (T2D) with a need for insulin intake
Test Group B: OBND, relatives who do not have T2D
Control Group C: Standard of care diet, individuals diagnosed with T2D with a need for insulin intake
Control Group D: Standard of care diet, relatives who do not have T2D
Based on the above reported studies and available data on blood sugar and lipid values, the investigators have identified that 18 individuals in each group will provide adequate statistical power (alpha=0.05, beta=0.85). While lost to follow up occurs, the investigators will enroll 20 individuals in each group. Thus, a total of 80 study individuals (test and control) will be enrolled. Data analyses will be performed according to per protocol as well as per intent to treat. Clinical examination procedures in medicine and dentistry will follow principles of good clinical practice. Study group assignment will be based on a randomization using the SPSS statistics package. A pre-baseline examination will be performed to ensure that all study individuals fulfill study requirements. The investigators will monitor that study individuals are compliant to protocol.
Study time schedule The study design includes a pre-baseline study examination two weeks before study start to ensure that study individuals meet the criteria for study participation and to control for Hawthorne effects. Study individuals will be enrolled in groups of 8 to 10 individuals and re-examined at baseline. The primary study endpoint is the third examination will be performed 4 weeks after baseline examination. A follow-up examination will occur after 6 months (plus/minus 14 days). All study enrollments will be completed within one month. Study individuals will receive phone calls during the study period to encourage compliance and respond to specific questions.
