title: Study design and methods for a randomized crossover trial substituting brown rice for white rice on diabetes risk factors in India.
abstract: India has the second largest number of people with diabetes in the world following China. Evidence indicates that consumption of whole grains can reduce the risk of type 2 diabetes. This article describes the study design and methods of a trial in progress evaluating the effects of substituting whole grain brown rice for polished (refined) white rice on biomarkers of diabetes risk (glucose metabolism, dyslipidemia, inflammation). This is a randomized controlled clinical trial with a crossover design conducted in Chennai, India among overweight but otherwise healthy volunteers aged 25-65 y with a body mass index ≥23 kg/m(2) and habitual rice consumption ≥200 g/day. The feasibility and cultural appropriateness of this type of intervention in the local environment will also be examined. If the intervention is efficacious, the findings can be incorporated into national-level policies which could include the provision of brown rice as an option or replacement for white rice in government institutions and food programs. This relatively simple dietary intervention has the potential to substantially diminish the burden of diabetes in Asia and elsewhere.
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Wedick
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Vasudevan
authors.initials: V
authors.lastname: Sudha
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Donna
authors.initials: D
authors.lastname: Spiegelman
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Mookambika Ramya
authors.initials: MR
authors.lastname: Bai
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Vasanti S
authors.initials: VS
authors.lastname: Malik
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Siva Sankari
authors.initials: SS
authors.lastname: Venkatachalam
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Vijayalaksmi
authors.initials: V
authors.lastname: Parthasarathy
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Ruchi
authors.initials: R
authors.lastname: Vaidya
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Lakshmipriya
authors.initials: L
authors.lastname: Nagarajan
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Kokila
authors.initials: K
authors.lastname: Arumugam
authors.affiliation: c Public Health and Community Medicine Department, Nutrition/Infection Unit, Tufts University School of Medicine , Boston , MA , USA.
authors.forename: Clara
authors.initials: C
authors.lastname: Jones
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Hannia
authors.initials: H
authors.lastname: Campos
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Kamala
authors.initials: K
authors.lastname: Krishnaswamy
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Walter
authors.initials: W
authors.lastname: Willett
authors.affiliation: a Departments of Nutrition, Epidemiology, Biostatistics and Global Health, Harvard School of Public Health , Boston , MA , USA .
authors.forename: Frank B
authors.initials: FB
authors.lastname: Hu
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Ranjit Mohan
authors.initials: RM
authors.lastname: Anjana
authors.affiliation: b Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, WHO Collaborating Centre for Non-Communicable Diseases, International Diabetes Federation (IDF) Centre of Education , Chennai , Tamil Nadu , India , and.
authors.forename: Viswanathan
authors.initials: V
authors.lastname: Mohan
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers; D015992:Body Mass Index; D002985:Clinical Protocols; D018592:Cross-Over Studies; D003469:Culture; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology / Q000517:prevention & control*; D004032:Diet; D004040:Dietary Carbohydrates; D002523:Edible Grain; D005247:Feeding Behavior; D005511:Food Handling; D038321:Glycemic Index; D006801:Humans; D007194:India; D008875:Middle Aged; D012275:Oryza; D012107:Research Design
chemical_list: D015415:Biomarkers; D004040:Dietary Carbohydrates
keywords: Global nutrition; intervention; whole grains