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NCT Number: NCT07309250

A Study on Gastrointestinal Transit Time at the Population Level

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This explorative study is designed as a cross-sectional investigation aimed at establishing population-level reference values for gastrointestinal transit time (GITT). Adult participants from the general population will undergo GITT measurement using the blue-dye method. This muffin contains blue colorant that cannot be absorbed; after ingestion, it passes through the entire gastrointestinal tract and is eventually excreted in feces. Following a two-day lifestyle standardization period (including dietary and activity guidance) to minimize potential confounding effects on gastrointestinal motility, participants will attend a clinical visit where they will ingest a blue muffin. GITT will be determined by measuring both the time interval between ingestion of the blue muffin and the first appearance of blue-colored stool, and the duration from its first appearance to its complete disappearance.

The blue muffin method has been well-established in previous research for GITT assessment. Building upon the methodology developed by Berry et al., we will introduce stricter pre-test condition controls (includes dietary advice and lifestyle recommendations) and optimized the blue muffin formulation.These improvements allow for reliable measurement with a single muffin administration, which has been evaluated through KU Leuven Health Pass in a large sample size(S-70168).

To investigate potential determinants and correlates of GITT, we will collect biochemical parameters, fecal moisture, and resting metabolic rate. Additionally, participants will complete 24-h diet record and health questionnaires assessing bowel movement, physical activity habits, stress levels, sleep quality and hydration condition for subsequent correlation analyses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Child-Pugh B or C, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4;
  • Immobility;
  • Neuromuscular degenerative conditions associated with muscular atrophy, such as myasthenia gravis, muscular dystrophies, fibromyalgia, or multiple Sclerosis;

Treatment and study plan

Diet

Other

Participants will consume a regular muffin containing blue dye

Primary outcomes

  1. Gastrointestinal transit time

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

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

Secondary outcomes

  1. Height (cm)

    Time frame: baseline

    Measured using a height meter, in centimeters.

  2. Weight (kg)

    Time frame: baseline

    Measuring using a scale, in kg.

  3. BMI

    Time frame: baseline

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

  4. Blood glucose (mmol/L)

    Time frame: baseline

    Measure blood glucose by CardioChek Plus in mmol/L

  5. Fat mass (kg)

    Time frame: baseline

    Using Bodystat quadscan 4000 to measure fat mass (kg)

  6. Lean body mass(kg)

    Time frame: baseline

    Using Bodystat quadscan 4000 to measure lean body mass (kg)

  7. Fat percentage (%)

    Time frame: baseline

    Using Bodystat quadscan 4000 to measure fat%

  8. Total cholesterol (mmol/L)

    Time frame: baseline

    Measuring by Mission cholesterol Meter in mmol/L

  9. HDL-C (mmol/L)

    Time frame: baseline

    Measuring by Mission cholesterol Meter in mmol/L

  10. LDL-C (mmol/L)

    Time frame: baseline

    Measuring by Mission cholesterol Meter in mmol/L

  11. Triglyceride (mmol/L)

    Time frame: baseline

    Measuring by Mission Cholesterol Meter in mmol/L

  12. Food record

    Time frame: 2 days after study

    Participants record their 24-h diets through smartphone application

  13. Stool form

    Time frame: baseline

    Stool form will be evaluated by Bristol Stool Form Scale, the score is from 1 to 7, with values closer to the middle indicating more ideal stool shape.

  14. Hydration status

    Time frame: baseline

    Hydration status will be rated from 1 to 8 by Urine color chart, with higher numbers indicating that the body needs more water.

  15. Perceived level of stress

    Time frame: baseline

    The10-item Perceived Stress will be used to measures an individual's perceived level of stress over the past month. The total score ranges from 0 to 40. A higher score indicates a greater perceived level of stress.

  16. Sleep quality

    Time frame: baseline

    Pittsburgh Sleep Quality Index will be used to assess subjective sleep quality over the past month. The total score ranges from 0 to 21. A higher score indicates poorer sleep quality.

  17. Activity level

    Time frame: baseline

    The Baecke Physical Activity Questionnaire will be used to assess daily habitual physical activity, with a particular focus on work-related and exercise-related activities. It does not produce a single total score, but rather scores on three dimensions, each typically ranging from 1 to 5. On each dimension, a higher score indicates a higher level of physical activity in that area. Therefore, for assessing activity levels, a higher score is generally better.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Matthys

CONTACT

[email protected]

+32 016342655

Wei Li

CONTACT

[email protected]

+32 016344539

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Gastrointestinal Transit Time at the Population Level: A Cross-sectional Study

Acronym: GITTPop

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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