A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes.

ABSTRACT

BACKGROUND: In the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. SUBJECTS: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27-45 kg m(-2); age, 40-75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel. RESULTS: A significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (-11.27% (95% confidence interval (CI) -10.17; -12.36)) compared with the control group (-5.88% (95% CI -3.79; -7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI 2.56; 7.61) and body weight (95% CI 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI -1.52; -33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl(-1) and <100 mg dl(-1), respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol(-1))) at 6 months. CONCLUSIONS: Both the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow-up in real-world conditions. The Ma-Pi diet resulted in greater improvement in glycemic control.