Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07690176

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity & Overweight

Full registry criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Drug use * Claustrophobia * Subjects who are on a weight loss diet or following a high calorific/high protein diet to gain weight * Subjects with functional constipation * Any known food allergies or intolerances to the 14 major food allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a malabsorption syndrome including coeliac disease * Subjects who have regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi or known or suspected irritable bowel syndrome * Currently taking part in another scientific research * Having received a product with 14C in the past 12 months * Pregnant or breastfeeding * Smoking or having used nicotine-containing products in the 6 months prior to the study. * Subjects who have taken antibiotics within the 60 days prior to the adaptation period. * Currently involved in a structured progressive resistance training programme (\>3 times per week) * Sedentary lifestyle as assessed using the International Physical Activity Questionnaire \[IPAQ\]. * Unable to give consent * Employed or undertaking a thesis or internship at the department of Human and Animal Physiology

Treatments and study arms

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.

Primary outcomes

Total mass balance (cumulative recovery of 14C)Baseline to 72 hours post dose

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Wageningen University and Research🇳🇱 Wageningen, Netherlands
Ayesha Heinis, PhDContact
Marlou Dirks, PhDContact