Personalized Glucose Optimization Through Nutritional Intervention
NCT03708419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242
Last updated 2022-02-14
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.
Conditions
- Obesity
- Pre-diabetic
- Type 2 Diabetes Mellitus
Interventions
- OTHER
-
Optimal diet
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.
- OTHER
-
Suboptimal diet
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.
Sponsors & Collaborators
-
Wageningen University and Research
collaborator OTHER -
Top Institute Food and Nutrition
collaborator OTHER -
Netherlands Organisation for Scientific Research
collaborator OTHER_GOV -
Maastricht University Medical Center
lead OTHER
Principal Investigators
-
Ellen E Blaak, Prof. · Maastricht University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-04
- Primary Completion
- 2021-11-29
- Completion
- 2021-11-29
Countries
- Netherlands
Study Locations
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