Health TrialsbyHealthPanel

A Study on Gastrointestinal Transit Time at the Population Level

ConditionGastrointestinal Transit Time
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKU Leuven

About this trial

The goal of this study is to investigate the baseline of gastrointestinal transit time (GITT) and explore its relationship with other health indicators in 932 healthy adult volunteers.

The main questions it aims to answer are:

What are the population-level baseline values for GITT using the blue dye method? How is GITT associated with key physiological parameters including blood metabolic markers, life style, and stool characteristics?

Participants will:

Consume a standardized blue dye muffin after overnight fasting at the research center; Offer a finger prock blood samples for metabolic profiling; Collect stool samples for moisture measurement; Complete detailed questionnaires on diet, lifestyle, and bowel habits; Record the time of first blue stool appearance to determine GITT.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-65 years old

18.5 kg/m² ≤ BMI ≤ 25 kg/m² or BMI ≥ 30 kg/m² (people with normal weight or obesity)

Provision of informed consent to participate.

Disqualifiers

Gastrointestinal conditions which may affect nutrient absorption or gastric emptying, including coeliac disease, Crohn's disease, previous resection of the small intestine other than bariatric surgery, gastroparesis;

Using medications which effect gastric motility (e.g., domperidone, erythromycin, metoclopramide, prucalopride, opiates, loperamide, …)

The ingredients of blue muffins include gluten, nuts, baking powder, sugar, vanilla extract and sunflower oil. Participants with allergies to these ingredients;

Current diagnosis of cancer;

Trial population

Healthy volunteers from the Flanders region who volunteered to participate in the research

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Diet

    Other intervention

    Participants will consume a regular muffin containing blue dye

Treatment groups

932 Participants
are divided into 1 treatment group
Group A: Adult participants1 intervention

Trial outcomes

Primary outcomes

1

Gastrointestinal transit time

Calculate the transit time by the recorded muffin consuming time, first blue stool appearance time and last blue stool appearance time

Time frame
From enrollment to the end of study at 2 weeks

Secondary outcomes

1

Height (cm)

Measured using a height meter, in centimeters.

Time frame
baseline
2

Weight (kg)

Measuring using a scale, in kg.

Time frame
baseline
3

BMI

weight and height will be combined to report BMI in kg/m\^2

Time frame
baseline
4

Blood glucose (mmol/L)

Measure blood glucose by CardioChek Plus in mmol/L

Time frame
baseline

Other outcomes

Sponsors and contacts

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

KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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