Status:

COMPLETED

Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses

Lead Sponsor:

Wageningen University and Research

Conditions:

Lipid Metabolism

Glucose Metabolism

Eligibility:

All Genders

45-75 years

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 car...

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

March 28 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 29 2022

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT05313594

Start Date

March 28 2022

End Date

June 29 2022

Last Update

July 6 2022

Active Locations (1)

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1

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands, 6708 WG