Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses
Condition: Lipid Metabolism; Glucose Metabolism
Study type: Observational

Summary: 
      Giving personalised dietary advice will help mitigate the postprandial increases in TG and
      glucose levels, and will assist in the battle against the increase in nutrition-related
      diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will
      be a first step to personalised dietary advice.

      The primary objective of this study is to validate the prediction model on the effect of a
      standardized mixed meal challenge on postprandial TG levels in a heterogenous group of
      middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the
      accuracy of the predicted postprandial TG responses by increasing the number of postprandial
      TG measurements, 2) to determine which parameters can improve the accuracy of the predicted
      postprandial TG responses, 3) to determine if we can predict the effect of a standardized
      mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged,
      overweight to obese individuals, and 4) to determine which parameters can improve the
      accuracy of the predicted postprandial glucose responses. Another objective is to validate
      dried blood spots postprandial triglyceride concentrations against venous blood
      concentrations.

      There are minor risks for the research subjects of this study. Research subjects will invest
      approximately 13.5 hours in the study. They will visit the Wageningen University research
      facility three times and Hospital Gelderse Vallei once.
    

Detailed description: 
      Elevated triglyceride (TG) and glucose levels are major risk factors for cardiovascular
      diseases. Therefore, mitigating the postprandial increase in TG and glucose levels may help
      curb a person's risk of developing cardiovascular diseases. Current strategies to stimulate
      people to adopt a healthy lifestyle, however, are still insufficient. This is partly due to
      the fact that nutritional advice is nowadays still given at the population level via general
      nutrition guidelines, while nutritionist have long been aware that what works for one person
      may not work for another. Giving personalised dietary advice will help mitigate the
      postprandial increases in TG and glucose levels, and will assist in the battle against the
      increase in nutrition-related diseases, such as cardiovascular diseases. Being able to
      predict postprandial responses, will be a first step to personalised dietary advice.

      The primary objective of this study is to validate the prediction model on the effect of a
      standardized mixed meal challenge on postprandial TG levels in a heterogenous group of
      middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the
      accuracy of the predicted postprandial TG responses by increasing the number of postprandial
      TG measurements, 2) to determine which parameters can improve the accuracy of the predicted
      postprandial TG responses, 3) to determine if we can predict the effect of a standardized
      mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged,
      overweight to obese individuals, and 4) to determine which parameters can improve the
      accuracy of the predicted postprandial glucose responses. Another objective is to validate
      dried blood spots postprandial triglyceride concentrations against venous blood
      concentrations.

      Digital twin is an observational study with three visits, including one mixed meal challenge
      test day.

      Study population consists of 38 volunteers, 45-75 year old, BMI between 25-35 kg/m2.

      The primary study parameter is the postprandial triglyceride responses in blood upon a mixed
      meal challenge. The secondary study parameters are: postprandial responses in the blood upon
      a mixed meal challenge, and extensive phenotyping of the subjects by collecting data on
      fasting blood profiles of micronutrients, metabolites, and proteins, continuous blood glucose
      levels (Freestyle Libre), body fat composition (DEXA), liver fat percentage (MRI), habitual
      dietary intake (FFQ), and physical activity (ActivPAL3).

      This study is related to a broad general population. There are minor risks for the research
      subjects of this study. Consumption of the liquid mixed meal may cause some gastro-intestinal
      discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit
      painful and may cause a bruise. The amount of blood that is drawn from subjects is within
      acceptable limits (total amount collected = 186mL). The radiation dose received during the
      DEXA scan for measuring body composition, is negligible compared to the average dose each
      person in the Netherlands receives per year. Research subjects will invest approximately 13.5
      hours in the study. They will visit the Wageningen University research facility three times:
      once for a short screening, once to collect phenotyping data, and once for a mixed-meal
      challenge test day. In addition, they will visit Hospital Gelderse Vallei once for an MRI
      measurement.
    

Intervention name(s): Mixed meal challenge test; MRI; DEXA; Freestyle Libre; ActivPAL3
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Device; Device
Intervention description(s): Mixed meal consumption followed by postprandial blood sampling; MRI imaging; DEXA scan; Continuous blood glucose measurement; Continuous physical activity measurement
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The population of the study will consist of generally healthy males and females aged 45-75,
        with a BMI ranging from 25 to 35 kg/m2. For this study, we will include 38 research
        subjects (aiming at 50% females).
      
Biospecimen description: 
      Blood plasma and serum
    
Keywords: postprandial; lipids; glucose; dried blood spot; prediction model; metabolic responses