Study design
T2D, diabetic
COMPLICATIONS
The study is a short-term randomized pilot case–control study including individuals with a diagnosis of T2D and using insulin. The randomization was performed by a study group coordinator otherwise not associated with the study and assigning subjects to groups depending on when the participants could come to the first examination. The test group received OBND. The control group received a standard of care diabetic designed diet. Prior to study start, and at end of study after 4 weeks, blood samples were collected and analyzed at the Kristianstad Hospital Medical Laboratory. Pertinent data regarding diabetic conditions and complications were collected from current patient records after the clinical examination had been performed. This was done by an experienced endocrinologist. Thereafter, all participants were examined by an experienced periodontist (GRP). Neither before the first, nor at the final examination were the medical and dental clinical examiners informed about study group assignments and without access to medical dental previous data. During 2018, all clinical examinations were performed at the Central Hospital in Kristianstad, Sweden. Following the medical examinations, the dental examinations were performed at the clinical dental office at the Central Hospital in Kristianstad. All examinations were performed at the same time of the day as the first and final serum samplings were performed, Dental examinations were performed at the Oral Surgery clinic at Kristianstad Central Hospital. No treatment of endocrinological or dental conditions were performed during the study. A licensed periodontist who has performed many clinical trials including calibration procedures (GRP) performed the clinical dental examinations. The examiners could not be blinded to whether study participants had started, or completed the study. This was due to the restrictions on how the meal portions were distributed. The blood analyses were, however, performed blinded as to study sequence.The OBND food was produced by Igelösa Life Science AB, Lund, Sweden. The standard hospital care diet (control) was produced by Blekedamm AB, Kristianstad, Sweden. The diet was delivered individually by a truck delivery service. During the study period, all participants received daily packages of prepared food given study assignments using specially designed cooling bags. These packages were distributed such that neither delivery personnel or recipients could identify provided diet. The bags with potential left-over food were returned through the delivery service to control for compliance. In not one single case was it possible to identify non-compliance.