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The Metabolic Effects of a Hyperglycaemic Meal in Lean and Obese Individuals Using a [14C]-Glucose Microtracer Approach

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn how a high-glycaemic meal affects the way the body processes glucose in healthy adults who are either lean or have obesity. The main questions it aims to answer are: Is the polyol pathway (conversion of glucose into sorbitol and fructose) more active after a hyperglycaemic meal? Is this pathway more active in individuals with obesity compared with lean individuals? We will compare people who eat a high-glycaemic meal with those who eat a low-glycaemic meal to see whether meal type changes how glucose is metabolized in the body. Participants will drink a small amount of 14C-labelled glucose so researchers can trace how the body uses glucose, spend one long study day (about 12 hours in the lab) plus short morning visits on days 2 to 4, and undergo repeated measurements, including blood sampling, breath sampling, indirect calorimetry, and complete urine and stool collection for 72 hours. This information will help us understand how glucose is processed in the body and whether people with obesity handle glucose differently than lean individuals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• Healthy males and females using contraception during and for 3 months after the study.

• Aged from 18-65 years at the time of signing informed consent

• 18.5 \< BMI \< 25 kg·m2 or 30\< BMI \<35 kg·m2

• Must be willing and able to communicate and participate in the whole study, including consumption of 14C-glucose and meals offered during study conduct

• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

• Must usually eat 3 meals per day (i.e. breakfast, lunch and dinner)

Locations
Other Locations
Netherlands
Wageningen University and Research
RECRUITING
Wageningen
Contact Information
Primary
Marlou Dirks, PhD
Marlou.Dirks@wur.nl
+31 317-484 136
Backup
Ayesha Heinis, PhD
ayesha.heinis@wur.nl
+31 6-21578392
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 24
Treatments
Experimental: A - Lean individuals (Low-glycemic breakfast)
Lean participants randomized to consume a low-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.
Experimental: B - Lean individuals (High-glycemic breakfast)
Lean participants randomized to consume a high-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.
Experimental: C - Individuals with obesity (High-glycemic breakfast)
Participants with obesity consume a high-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.
Related Therapeutic Areas
Sponsors
Collaborators: Bonumose, Inc., TNO
Leads: Wageningen University

This content was sourced from clinicaltrials.gov

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