title: A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Soare
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Del Toro
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: Y M
authors.initials: YM
authors.lastname: Khazrai
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: A
authors.identifier: 0000-0002-6844-5108
authors.initials: A
authors.lastname: Di Mauro
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Fallucca
authors.affiliation: Department of Laboratory Medicine, University Campus Bio-Medico of Rome, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Angeletti
authors.affiliation: Center of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Ancona, Italy.
authors.forename: E
authors.identifier: 0000-0001-7940-6748
authors.initials: E
authors.lastname: Skrami
authors.affiliation: Center of Epidemiology, Biostatistics and Medical Information Technology, Polytechnic Marche University, Ancona, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Gesuita
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Tuccinardi
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Manfrini
authors.affiliation: Department of Clinical Sciences, La Sapienza University II Faculty, Rome, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Fallucca
authors.affiliation: International Study Center for Environment, Agriculture, Food, Health and Economics, Tolentino, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Pianesi
authors.affiliation: Unit of Endocrinology and Diabetes, Department of Medicine, University Campus Bio-Medico, Rome, Italy.|Centre for Immunobiology, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Pozzilli
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy*; D015623:Diet, Macrobiotic; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D008055:Lipids