Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses

Sponsor

Wageningen University and Research (Other)

Overall Status

Completed

CT.gov ID

NCT05313594

Collaborator

(none)

Enrollment

Location

3.1

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lipid Metabolism Glucose Metabolism	Diagnostic Test: Mixed meal challenge test Diagnostic Test: MRI Diagnostic Test: DEXA Device: Freestyle Libre Device: ActivPAL3

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.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses

Actual Study Start Date :

Mar 28, 2022

Actual Primary Completion Date :

Jun 14, 2022

Actual Study Completion Date :

Jun 29, 2022

Outcome Measures

Primary Outcome Measures

Postprandial triglycerides blood levels [Baseline]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [15 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [30 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [45 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [60 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [90 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [120 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [150 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [180 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [210 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [240 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [270 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [300 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [330 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [360 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [390 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [420 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [450 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels [480 minutes post-ingestion]
Postprandial triglyceride responses in blood upon a mixed meal challenge

Secondary Outcome Measures

Postprandial glucose blood levels [Baseline]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [15 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [30 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [45 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [60 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [90 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [120 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [150 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [180 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [210 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [240 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial glucose blood levels [480 minutes post-ingestion]
Postprandial glucose responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [Baseline]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [15 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [30 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [60 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [90 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [120 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [150 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [180 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [210 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [240 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge
Postprandial insulin blood levels [480 minutes post-ingestion]
Postprandial insulin responses in blood upon a mixed meal challenge

Other Outcome Measures

Blood glucose profile [Continuous for 5 days]
Continuous blood glucose levels
Physical activity [Continuous for 5 days]
Continuous physical activity levels
Anthropometrics [Baseline]
Waist-to-hip ratio
Body composition [Baseline]
Body composition measurement with Dexa scan
Habitual dietary intake [Baseline]
Habitual dietary intake assessment with FFQ
Liver fat [Baseline]
Liver fat percentage assessment with MRI
Micronutrient levels in blood [Baseline]
Micronutrient levels
Metabolite levels in blood (full profile) [Baseline]
Metabolomics
Protein levels in blood (full profile) [Baseline]
Proteomics
Triglyceride blood levels [Baseline]
Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge
Triglyceride blood levels [120 minutes post-ingestion]
Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge
Triglyceride blood levels [240 minutes post-ingestion]
Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge
Triglyceride blood levels [480 minutes post-ingestion]
Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female
Age 45-75 y
BMI 25-35 kg/m2
Suitable veins for insertion of cannula

Exclusion Criteria:

Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis
Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy
Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor
Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor
Blood clotting disorders
Unstable body weight (weight gain or loss >3 kg in the past three months)
Reported slimming, medically prescribed or other extreme diets
Alcohol consumption >21 glasses a week
Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men; checked at screening)
Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
Having a pacemaker, implantable cardioverter-defibrillator, hearing implant, internal insulin pump, neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye
Having claustrophobia
Not willing to give up blood donation during the study
Food allergies or intolerances for products that we use in the study
Unwilling to consume non-vegan test meal
Recent use of antibiotics (<3 months prior to study start)
Current smokers
Abuse of soft and/or hard drugs
Participation in another clinical trial at the same time
Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or Human Nutrition and Health Department of Wageningen University