Study population and selection criteria
co-morbidity, T2D, HCC
RHEUMATOID ARTHRITIS, GLUTEN INTOLERANCE, RECRUITMENT
Consistent with Swedish law and the Helsinki Declaration of 1964 with all amendments, the Swedish Ethical Review Authority Regional Ethical Committee in Lund, Sweden (Institutional Review Board case no. 2017/540) approved the study. The study was performed 2017. Informed consent was obtained from those who were recruited from the Health Care Center (HCC) connected to the Endocrinology Clinic at Kristianstad Central Hospital, Sweden. Clinicians involved in the care of potential study participants were neither involved in the recruitment, nor did they perform study procedures. Study individuals were randomly assigned to the test (OBND), or to the standard of care diet (control group). The assignment to groups were made by the HCC using a computer assigned data program.The study inclusion criteria were: (I) study individuals age ≥ 18 years, and (II) having a confirmed diagnosis of T2D. The exclusion criteria were: (I) current need for antibiotic treatment, or a history of treatment with antibiotics during the preceding month, (II) a systolic blood pressure > 180 mm Hg, (III) having visited a dental clinic within 3 months prior to study start, (IV) being a current smoker, snuff user, (V) currently pregnant, (VI) suffering from rheumatoid arthritis, (VII) being diagnosed with lactose- or gluten intolerance, or (VIII) having any other severe co-morbidity. A total of 199 potential study individuals with T2D were recruited from medical records with a follow up period of ≥ 5 years and with stable serum Hb1Ac. A total of 30 individuals gave written consent to participate.