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

NCT07690176 | Recruiting

• 1 other identifier: NL85522.028.24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Keywords

Hyperglycaemic meal; 14C-glucose; microtracer; accelerator mass spectrometry; polyol pathway; de novo lipogenesis; arteriovenous forearm balance

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 72 hours post dose

Secondary Outcomes (10)

• Polyol pathway activity (fructose-to-glucose ratio)

  Baseline to 72 hours post 14C ingestion

• Polyol pathway activity (sorbitol-to-glucose ratio)

  Baseline to 72 hours post 14C ingestion

• Polyol pathway activity (AUC-based ratio)

  Baseline to 72 hours post 14C ingestion

• De novo lipogenesis from glucose

  Baseline to 72 hours

• Caloric value of glucose

  Baseline to 72 hours

Other Outcomes (9)

• Polyol Pathway Activity Markers

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

• Plasma glucose

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

• Insulin

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

Study Arms (3)

A - Lean individuals (Low-glycemic breakfast)

EXPERIMENTAL

Lean participants randomized to consume a low-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.

Dietary Supplement: Low-glycemic breakfast (randomized vs high glycemic)

B - Lean individuals (High-glycemic breakfast)

EXPERIMENTAL

Lean participants randomized to consume a high-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.

Dietary Supplement: High-glycaemic breakfast (randomized vs low glycemic)

C - Individuals with obesity (High-glycemic breakfast)

EXPERIMENTAL

Participants with obesity consume a high-glycemic breakfast prior to administration of an oral \[¹⁴C\]-glucose microtracer to assess postprandial glucose metabolism.

Dietary Supplement: High-glycaemic breakfast

Interventions

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.

A - Lean individuals (Low-glycemic breakfast)

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.

B - Lean individuals (High-glycemic breakfast)

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.

C - Individuals with obesity (High-glycemic breakfast)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \< 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)

You may not qualify if:

• 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
• Any diagnosed respiratory disease, such as COPD or asthma
• Any previous motor disorders or disorders in muscle and/or lipid metabolism
• Known severe kidney problems
• Presence of an ulcer in the stomach or gut and/or strong history of indigestion
• Recent or chronic history of diarrhoea
• Known anaemia
• A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
• Regular use of dietary supplements (\>3 times per week)
• Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
• History of any drug or alcohol abuse in the past two years
• A confirmed positive alcohol breath test at screening or admission

Sponsors & Collaborators

• Wageningen University: lead
• Bonumose, Inc.: collaborator
• TNO: collaborator

Study Sites (1)

Wageningen University and Research

Wageningen, 6708 WD, Netherlands

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlou Dirks, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlou Dirks, PhD

CONTACT

+31 317-484 136; Marlou.Dirks@wur.nl

Ayesha Heinis, PhD

CONTACT

+31 6-21578392; ayesha.heinis@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: Single-centre, open-label, parallel assignment with three arms. Lean participants are randomized to receive either a low-glycaemic or high-glycaemic breakfast; obese participants receive a high-glycaemic breakfast (non-randomized). All participants ingest a microtracer dose of \[14C\]-glucose (≤10 kBq/270 nCi) immediately after breakfast to enable metabolic tracing via accelerator mass spectrometry (AMS). The study includes repeated indirect calorimetry, serial blood sampling (including forearm arteriovenous balance), expired air collection, and 72-hour urine and feces collection to assess polyol pathway activity, de novo lipogenesis, and energy metabolism.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: July 8, 2026
• Study Start: February 24, 2026
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)