The Effect of the Macrobiotic Ma-Pi 2 Diet vs. the Recommended Diet in the Management of Type 2 Diabetes

The Randomized Controlled MADIAB Trial

Andreea Soare; Yeganeh M Khazrai; Rossella Del Toro; Elena Roncella; Lucia Fontana; Sara Fallucca; Silvia Angeletti; Valeria Formisano; Francesca Capata; Vladimir Ruiz; Carmen Porrata; Edlira Skrami; Rosaria Gesuita; Silvia Manfrini; Francesco Fallucca; Mario Pianesi; Paolo Pozzilli

Disclosures

Nutr Metab. 2014;11(39) 

In This Article

Results

A total of 200 patients were screened and 56 were considered eligible for recruitment.

Baseline demographic and clinical features of patients are presented in Table 3. There were no significant differences between groups. Analysis of diets in the 6 months prior to the trial showed little difference between groups, with an average daily energy intake of 1988 (SD 368.2) kcal for the Ma-Pi 2 group and 1964 (SD 294.3) kcal for the control group (p = 0.802). Nutritional composition was also similar in the Ma-Pi 2 group (18.2% protein, 36.2% fat, 45.6% carbohydrate, 10.3 g/1000 kcal of fiber) versus the control group (19.3% protein, 35.4% fat, 45.3% carbohydrate, 10.8 g/1000 kcal of fiber).

The 56 eligible patients were randomly assigned to the Ma-Pi 2 diet group (n = 28) and the control group (n = 28). Reasons for exclusion were failure to meet inclusion criteria (n = 90), inability to attend residential schedule (n = 45), and failure to keep interview appointment (n = 9). The CONSORT diagram reflecting flow of study participants through the study is shown in Figure 3. Both groups experienced drop outs after randomization but before receiving any intervention; 3 patients in the Ma-Pi 2 diet group and 2 in the control group. Reasons for discontinuation included patient reluctance to change diet (1 patient in the Ma-Pi 2 group) and personal problems that prevented patients remaining in the assigned hotel for the study duration (2 patients in the Ma-Pi 2 group and 2 patients in the control group). Therefore a total of 51 patients, 25 in the Ma-Pi 2 group and 26 in the control group, completed the trial and were included in the modified ITT (mITT) analysis. The modified intention-to-treat was carried out for all patients who had FBG and PPBG results for at least the first week following randomization.

Figure 3.

Consort diagram reflecting flow of study participants through the study.

Daily average energy intake during the trial was 1803 (SD 95.2) kcal (11.8% protein, 15.2% fat, and 73.0% carbohydrates, with 29 g/1000 kcal fiber) in the Ma-Pi 2 group, and 1798 (SD 106.3) kcal (18.4% protein, 32.3% fat, and 49.3% carbohydrates, with 20.5 g/1000 kcal fiber) for the control group (p = 0.860). For the Ma-Pi 2 diet the daily average amount of carbohydrate was 335.7 g. As for the control diet the daily average amount of carbohydrate was 235.8 g (p < 0.001).

Figure 1 shows the primary and secondary outcomes results. A significant reduction was observed in both groups for FBG and for PPBG. The reduction in PPBG (p = 0.035) levels was significantly greater in patients in the Ma-Pi 2 group compared with those in the control group.

Regarding secondary outcomes, the Ma-Pi 2 group showed a significantly greater reduction in HbA1c (p = 0.002) levels compared with those in the control group. Significantly greater median percentage reductions were observed for total cholesterol, LDLc, and the LDL/HDL ratio in the Ma-Pi 2 group versus the control group (p < 0.001). No significant change was observed for HDLc levels from baseline between groups and within groups (p = 0.283). Median BMI and weight were significantly reduced in both groups, and those reductions were significantly higher in the Ma-Pi 2 group compared with the control group (p < 0.001) (Table 4).

A non-parametric longitudinal data analysis of the daily FBG and PPBG evidenced a trend curve reduction in both groups over time (p < 0.001), with a higher tendency in the macrobiotic Ma-Pi 2 diet group (p < 0.001). Furthermore, the duration and the type of diet positively influenced the reduction of both FBG and PPBG (p < 0.001) (Figure 2).

The results of the multiple quantile regression analysis (adjusted for age, gender, BMI at baseline, and physical activity) are reported in Table 1. A significantly higher percentage reduction of FBG, PPBG, and HbA1c were associated with the Ma-Pi 2 diet, and a statistically significant higher effect on the percentage reductions in the same group was obtained for total cholesterol, LDL-cholesterol and LDL/HDL ratio, BMI, weight, and waist and hip circumference compared with the control group. The Ma-Pi 2 diet group experienced a significantly greater reduction of HOMA-IR (adjusted for wrist circumference) compared with the control group. No statistically significant changes in HDL-cholesterol levels were noted in either group, whereas the control diet group showed a significantly higher effect in the reduction of triglyceride levels compared to the Ma-Pi 2 group even though a reduction in triglycerides levels was obtained in both groups, none of the study participants had triglyceride values in the higher range after intervention.

Table 2 shows the results obtained by comparing both groups in the achievement and maintenance of FBG and PPBG. The percentage of patients who achieved FBG and PPBG target levels was significantly higher in the Ma-Pi 2 group compared with the control group. No significant difference was found in the percentage of patients that maintained the glycemic target level (both fasting and postprandial capillary glucose) between T0 and T21 (Figure 4). For some patients, OAD therapy had to be reduced to avoid hypoglycemia. A statistically significant reduction in OAD therapy occurred in the Ma-Pi 2 group compared with the control group (p = 0.018); from a total of 7 patients on sulfonylurea or glinide and/or DPP-4 inhibitor treatment at baseline, 5 suspended treatment (resulting in a total daily reduction of 8.5 mg of glinide, 200 mg glicazide, and 10 mg glibencamide). There were no episodes of hypoglycaemia in both the intervention group and the control group even though in the Ma-Pi 2 group there was a tendency for lower blood glucose levels. In the control group only 1 patient suspended OAD treatment (equating to a total reduction of 60 mg glicazide). Compliance was good in all patients, with no meals missed by any patient in either group. There were no reported severe AEs. Pedometer readings revealed no significant difference in the intensity of physical activity or duration between the 2 groups.

Figure 4.

Percentage of patients who achieved or maintained target blood glucose levels after 21 days of dietary treatment.

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