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Open Access Research

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 Soare1, Yeganeh M Khazrai1, Rossella Del Toro1, Elena Roncella1, Lucia Fontana2, Sara Fallucca1, Silvia Angeletti3, Valeria Formisano1, Francesca Capata1, Vladimir Ruiz4, Carmen Porrata5, Edlira Skrami6, Rosaria Gesuita6, Silvia Manfrini1, Francesco Fallucca7, Mario Pianesi8, Paolo Pozzilli1* and for the MADIAB Group1

Author Affiliations

1 Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy

2 Unit of Dietology and Diabetology, Sandro Pertini Hospital, Via dei Monti Tiburtini 385, 00157 Rome, Italy

3 Department of Laboratory Medicine, University Campus Bio-Medico, Rome, Italy

4 Department of Biochemistry and Physiology, Institute of Nutrition and Food Hygiene, Infanta 1158, 10300 Havana, Cuba

5 Clinical Assay Direction, Finlay Institute, Avenue 27, No. 19805, La Coronela, La Lisa 11600, Havana, Cuba

6 Center of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Via Tronto 10A, 60020 Ancona, Italy

7 Department of Clinical Sciences, La Sapienza University II Faculty, Via di Grottarossa 1035/1039, 00189 Rome, Italy

8 International Study Center for Environment, Agriculture, Food, Health and Economics, Via San Nicola, 62029 Rome, Italy

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Nutrition & Metabolism 2014, 11:39  doi:10.1186/1743-7075-11-39

Published: 25 August 2014

Abstract

Background

Diet is an important component of type 2 diabetes therapy. Low adherence to current therapeutic diets points out to the need for alternative dietary approaches. This study evaluated the effect of a different dietary approach, the macrobiotic Ma-Pi 2 diet, and compared it with standard diets recommended for patients with type 2 diabetes.

Methods

A randomized, controlled, open-label, 21-day trial was undertaken in patients with type 2 diabetes comparing the Ma-Pi 2 diet with standard (control) diet recommended by professional societies for treatment of type 2 diabetes. Changes in fasting blood glucose (FBG) and post-prandial blood glucose (PPBG) were primary outcomes. HbA1c, insulin resistance (IR), lipid panel and anthropometrics were secondary outcomes.

Results

After correcting for age, gender, BMI at baseline, and physical activity, there was a significantly greater reduction in the primary outcomes FBG (95% CI: 1.79; 13.46) and PPBG (95% CI: 5.39; 31.44) in those patients receiving the Ma-Pi 2 diet compared with those receiving the control diet. Statistically significantly greater reductions in the secondary outcomes, HbA1c (95% CI: 1.28; 5.46), insulin resistance, total cholesterol, LDL cholesterol and LDL/HDL ratio, BMI, body weight, waist and hip circumference were also found in the Ma-Pi 2 diet group compared with the control diet group. The latter group had a significantly greater reduction of triglycerides compared with the Ma-Pi 2 diet group.

Conclusions

Intervention with a short-term Ma-Pi 2 diet resulted in significantly greater improvements in metabolic control in patients with type 2 diabetes compared with intervention with standard diets recommended for these patients.

Trial registration

Current Controlled Trials ISRCTN10467793.

Keywords:
Fasting blood glucose; Macrobiotic diet; Type 2 diabetes