Personalized Glucose Optimization Through Nutritional Intervention
Condition: Obesity; Pre-diabetic; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional

Summary: 
      Maintaining well-controlled blood glucose concentrations is essential in the prevention of
      chronic cardiometabolic diseases. The blood glucose response to dietary and/or lifestyle
      patterns may vary between individuals. Insulin resistance in specific metabolic organs such
      as skeletal muscle, adipose tissue or the liver may underlie differential blood glucose
      responses.

      This dietary intervention study aims to obtain insight into the metabolic and lifestyle
      determinants of postprandial blood glucose responses, and to establish the effect of
      macronutrient manipulation of a 12-week dietary intervention on blood glucose homeostasis in
      metabolically different subgroups an its relationship to physical and mental performance and
      well-being.
    

Detailed description: 
      Study design: this study is a double-blinded, randomised, controlled, parallel design dietary
      intervention study. The study will be conducted at Maastricht University and Wageningen
      University and Research, the Netherlands.

      Study population: the study population will consist of 240 men and women between 40-75 years
      old, with a BMI 25-40 kg/m2. Participants will be either muscle insulin resistant (MIR) or
      liver insulin resistant (LIR), as classified by an oral glucose tolerance test (OGTT) during
      the screening procedure. A subgroup of 80 participants will be selected for detailed
      metabolic phenotyping.

      Intervention: for 12 weeks, participants will receive either a diet optimal for MIR (high in
      mono-unsaturated fatty acids) or a diet optimal for LIR (high in protein and fiber, low in
      fat) with respect to changes in disposition index. Participants will be randomly allocated to
      one of the two diets. Detailed laboratory and daily life phenotyping will be done pre- and
      post intervention.
    

Intervention name(s): Optimal diet; Suboptimal diet
Intervention type(s): Other; Other
Intervention description(s): Based on a 7-points OGTT, participants will be classified as MIR or LIR. The hypothesized optimal diet for MIR has a moderate fat content which is high in mono- unsaturated fatty acids (HMUFA) with a macronutrient breakdown of 38 E% from fat (20% MUFA, 10% polyunsaturated fatty acids (PUFA), 8% saturated fatty acids (SFA)), 48 E% from carbohydrates (CHO, 35% complex), and 14 E% from protein (35-40% plant protein). The hypothesized optimal diet for LIR is low in fat, high in protein (LFHP) and increased fiber with a macronutrient breakdown of <28 E% from fat (10% MUFA, 10% PUFA, 8% SFA), 48 E% from CHO (35% complex), and 24 E% from protein (35-40% plant protein), and an additional supplement of 6g of soluble fiber per day. Participants wil be randomly allocated to one of the two diets.; The optimal diet for the other metabolic phenotype will be considered as "suboptimal"/ control diet. For the MIR phenotype this is the high protein, high fiber, low fat diet; for the LIR phenotype this is the high monounsaturated fatty acid diet. See the description above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insulin resistance; Personalized nutrition