title: A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN.
abstract: BACKGROUND
  Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants' weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets.
  
  
  METHODS
  We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood lipids, blood pressure, C-reactive protein, body composition, quality of life, subjective experience with the two diets, satiety scores and changes in medication.
  
  
  CONCLUSIONS
  Using these results, we will assess the need to conduct larger and longer studies with similar design.
  
  
  BACKGROUND
  This trial was registered at clinicaltrials.gov as NCT01891955 and Spanish Agency of Medication and Sanitary Products (AEMPS) registration code: MFV-ADI-2013-01.
authors.affiliation: Department of Clinical Sciences, Center for Primary Health Care Research, Lund University/Region Skåne, Malmö, Sweden. maelan.fontes_villalba@med.lu.se.
authors.forename: Maelán
authors.initials: M
authors.lastname: Fontes-Villalba
authors.forename: Tommy
authors.initials: T
authors.lastname: Jönsson
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Granfeldt
authors.forename: Lynda A
authors.initials: LA
authors.lastname: Frassetto
authors.forename: Jan
authors.initials: J
authors.lastname: Sundquist
authors.forename: Kristina
authors.initials: K
authors.lastname: Sundquist
authors.forename: Pedro
authors.initials: P
authors.lastname: Carrera-Bastos
authors.forename: María
authors.initials: M
authors.lastname: Fika-Hernándo
authors.forename: Óscar
authors.initials: Ó
authors.lastname: Picazo
authors.forename: Staffan
authors.initials: S
authors.lastname: Lindeberg
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D002985:Clinical Protocols; D018592:Cross-Over Studies; D003611:Dairy Products; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology; D004032:Diet; D002523:Edible Grain; D005260:Female; D006801:Humans; D008297:Male; D015596:Nutrition Assessment; D009752:Nutritional Status; D010865:Pilot Projects; D012107:Research Design; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose