title: 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.
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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10467793.
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Andreea
authors.initials: A
authors.lastname: Soare
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Yeganeh M
authors.initials: YM
authors.lastname: Khazrai
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Del Toro
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Roncella
authors.affiliation: Unit of Dietology and Diabetology, Sandro Pertini Hospital, Via dei Monti Tiburtini 385, 00157 Rome, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Fontana
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Fallucca
authors.affiliation: Department of Laboratory Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Angeletti
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Formisano
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Capata
authors.affiliation: Department of Biochemistry and Physiology, Institute of Nutrition and Food Hygiene, Infanta 1158, 10300 Havana, Cuba.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Ruiz
authors.affiliation: Clinical Assay Direction, Finlay Institute, Avenue 27, No. 19805, La Coronela, La Lisa 11600, Havana, Cuba.
authors.forename: Carmen
authors.initials: C
authors.lastname: Porrata
authors.affiliation: Center of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Via Tronto 10A, 60020 Ancona, Italy.
authors.forename: Edlira
authors.initials: E
authors.lastname: Skrami
authors.affiliation: Center of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Via Tronto 10A, 60020 Ancona, Italy.
authors.forename: Rosaria
authors.initials: R
authors.lastname: Gesuita
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
authors.affiliation: Department of Clinical Sciences, La Sapienza University II Faculty, Via di Grottarossa 1035/1039, 00189 Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Fallucca
authors.affiliation: International Study Center for Environment, Agriculture, Food, Health and Economics, Via San Nicola, 62029 Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Pianesi
authors.affiliation: Department of Endocrinology and Diabetes, University Campus Bio-Medico, Via Alvaro del Portillo 21, 00128 Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
keywords: Fasting blood glucose; Macrobiotic diet; Type 2 diabetes