NCT05313594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

March 15, 2022

Last Update Submit

July 4, 2022

Conditions

Lipid MetabolismGlucose Metabolism

Keywords

postprandiallipidsglucosedried blood spotprediction modelmetabolic responses

Outcome Measures

Primary Outcomes (19)

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    Baseline

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    15 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    30 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    45 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    60 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    90 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    120 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    150 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    180 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    210 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    240 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    270 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    300 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    330 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    360 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    390 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    420 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    450 minutes post-ingestion

  • Postprandial triglycerides blood levels

    Postprandial triglyceride responses in blood upon a mixed meal challenge

    480 minutes post-ingestion

Secondary Outcomes (23)

  • Postprandial glucose blood levels

    Baseline

  • Postprandial glucose blood levels

    15 minutes post-ingestion

  • Postprandial glucose blood levels

    30 minutes post-ingestion

  • Postprandial glucose blood levels

    45 minutes post-ingestion

  • Postprandial glucose blood levels

    60 minutes post-ingestion

  • +18 more secondary outcomes

Other Outcomes (13)

  • Blood glucose profile

    Continuous for 5 days

  • Physical activity

    Continuous for 5 days

  • Anthropometrics

    Baseline

  • +10 more other outcomes

Interventions

Mixed meal challenge testDIAGNOSTIC_TEST

Mixed meal consumption followed by postprandial blood sampling

MRIDIAGNOSTIC_TEST

MRI imaging

DEXADIAGNOSTIC_TEST

DEXA scan

Freestyle LibreDEVICE

Continuous blood glucose measurement

ActivPAL3DEVICE

Continuous physical activity measurement

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma and serum

Study Officials

  • Diederik J Esser, PhD

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Coordinator

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 6, 2022

Study Start

March 28, 2022

Primary Completion

June 14, 2022

Study Completion

June 29, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)