How the Body Processes Sugar After Eating, in People With Different Body Weights

ConditionObesity & Overweight

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorWageningen University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Diabetes (Type 1, Type 2, or genetic form of diabetes)

Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)

HbA1c higher than 53 mmol/mol

History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological, or psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

Low-glycemic breakfast (randomized vs high glycemic)
Dietary supplement
Participants receive a single oral microtracer dose of \[14C\] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a low glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (\~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
High-glycaemic breakfast (randomized vs low glycemic)
Dietary supplement
Participants receive a single oral microtracer dose of \[14C\] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (\~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
High-glycaemic breakfast
Dietary supplement
Participants receive a single oral microtracer dose of \[14C\] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast. The dose is prepared fresh on the morning of administration and consumed as a liquid drink. This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (\~0.006 mSv). The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: A - Lean individuals (Low-glycemic breakfast)Experimental treatment 1 intervention

Group B: B - Lean individuals (High-glycemic breakfast)Experimental treatment 1 intervention

Group C: C - Individuals with obesity (High-glycemic breakfast)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Total mass balance (cumulative recovery of 14C)

Cumulative recovery of total radioactivity across all excreta (urine, faeces, and expired CO₂) expressed as percentage of the administered dose.

Time frame

Baseline to 72 hours post dose

Secondary outcomes

Polyol pathway activity (fructose-to-glucose ratio)

Ratio of 14C-fructose to 14C-glucose concentrations

Time frame

Baseline to 72 hours post 14C ingestion

Polyol pathway activity (sorbitol-to-glucose ratio)

Ratio of 14C-sorbitol to 14C-glucose concentrations

Time frame

Baseline to 72 hours post 14C ingestion

Polyol pathway activity (AUC-based ratio)

Ratio of area under the curve (AUC) for 14C-fructose to AUC for 14C-glucose

Time frame

Baseline to 72 hours post 14C ingestion

De novo lipogenesis from glucose

Incorporation of 14C label into plasma lipids as a measure of fatty acid synthesis from glucose

Time frame

Baseline to 72 hours

Other outcomes

Polyol Pathway Activity Markers

Plasma and erythrocyte sorbitol concentrations

Time frame

Baseline and up to 8 hours after 14C-glucose ingestion

Plasma glucose

Plasma glucose concentration

Time frame

Baseline and up to 8 hours after 14C-glucose ingestion

Insulin

Serum insulin concentration

Time frame

Baseline and up to 8 hours after 14C-glucose ingestion

Exploratory Metabolic Phenotyping

Metabolomic, proteomic, and/or transcriptomic profiles in plasma and erythrocytes

Time frame

Baseline and up to 8 hours after 14C-glucose ingestion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wageningen University

Lead sponsor

Bonumose, Inc.

Collaborator

TNO

Collaborator

Source ClinicalTrials.gov

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