Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses

NCT05313594 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2022-07-06

No results posted yet for this study

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.

Conditions

  • Lipid Metabolism
  • Glucose Metabolism

Interventions

DIAGNOSTIC_TEST

Mixed meal challenge test

Mixed meal consumption followed by postprandial blood sampling

DIAGNOSTIC_TEST

MRI

MRI imaging

DIAGNOSTIC_TEST

DEXA

DEXA scan

DEVICE

Freestyle Libre

Continuous blood glucose measurement

DEVICE

ActivPAL3

Continuous physical activity measurement

Sponsors & Collaborators

  • Wageningen University and Research

    lead OTHER

Principal Investigators

  • Diederik J Esser, PhD · Wageningen University & Research

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2022-06-14
Completion
2022-06-29

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313594 on ClinicalTrials.gov