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Completed

NCT Number: NCT06377956

The Associations Between Gut Length, Gut Microbiota and Food Assimilation

The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenzhen Institute of Advanced Technology

Shenzhen, Guangdong, 518055, China

About this study

The focus of this work is to characterize the relationship between gut length, gut microbiota and food energy assimilation rate in healthy individuals.

The gut will be scanned using Magnetic Resonance Imaging (MRI) to calculate gut length. To obtain clearer images, volunteers will be asked to drink 1/1.5 sachet of He Shuang (polyethylene glycol electrolyte powder, molecular weight of 4000) and injected Raceanisodamine Hydrochloride Injection with 10 mg by intramuscular. Volunteers will be asked to drink He Shuang, which dissolved in 1/1.5L of water for the purpose of filling the intestines. As a contrast to improve imaging during scanning.

Volunteers will be given the experimental meal, which providing enough energy for volunteers to eat as much as they want. Feces and urine will be collected to calculate the assimilation rate. To more accurately label the food, edible polyethylene glycol with a molecular weight of 3350(PEG3350) is used. Provides 1.5g of PEG3350 per day, to be used with meals. PEG3350 reaches a steady state in the intestinal tract for 3 days. Food will be provided for seven days during the test period, the first three days are aimed at stabilizing the PEG3350 in the intestine, and the samples to be counted are mainly collected in the last four days. Food assimilation rate and metabolizable energy will be calculated for the 4-day.

The gut microbiota will be analyzed by metagenomics and metabolomics. This study combines metabolomics analysis techniques with imaging and physiological measurements to focus on the potential relationship between gut length and food absorption rates. Researchers anticipate recruiting up to 100 healthy volunteers (body mass index ≥ 18.5).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18-40 years old, healthy and disease free.
  • Regular bowel movements.

Exclusion criteria

  • Individuals who are constipated or suffer from intestinal disorders;
  • Individuals with mental illnesses such as depression and claustrophobia;
  • Individuals with glaucoma and prostate hypertrophy;
  • Metal implants in the body;
  • Pregnant and lactating women;
  • Individuals with blood phobia, pathologic hypotension or hypertension;
  • Use of antibiotics, probiotics, oral laxatives within 8 weeks;
  • Individuals with metabolic diseases (e.g., chronic diseases such as diabetes mellitus); recent weight loss due to various medical reasons;
  • Individuals with infectious diseases (e.g. HIV);
  • Irregular diet, lifestyle, addiction to tobacco, alcohol or drugs.

Treatment and study plan

Observation without intervention

Other

Observation of gut length, food intake, fecal and urine calories, body composition, microbiota, metabolic rate, metabolomics.

Primary outcomes

  1. Gut length

    Time frame: Through study completion for one year, will be measured on arrival.

    Volunteers will be scanned Magnetic Resonance Imaging(Shanghai united imaging, uMR 790).

  2. Energy intake

    Time frame: Through study completion for one year, will be measured on arrival.

    Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in KJ (kilojoule).

  3. Fecal energy

    Time frame: Through study completion for one year, will be measured on arrival

    Measuring the heat produced by burning dried feces using an oxygen bomb calorimeter (Parr6400). The total energy per gram tissue will be calculated in kJ (kilojoule)/g.

  4. Microbiome/Microbiota

    Time frame: Through study completion for one year, will be measured on arrival.

    Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.

  5. Metabolites

    Time frame: Through study completion for one year, will be measured on arrival.

    Abundance of metabolites will be from metabolomic profiling of feces by LC-MS (liquid chromatography mass spectrometry).

Secondary outcomes

  1. Urine energy content

    Time frame: Through study completion for one year, will be measured on arrival.

    Energy content will be evaluated by measuring the heat energy produced when burning dried urine using an oxygen bomb calorimeter (Parr6400). The total energy per gram tissue will be calculated in kJ (kilojoule)/g.

  2. Body weight

    Time frame: Through study completion for one year, will be measured on arrival.

    Volunteers will be asked to fast for 10 hours and measured fasting weight.

  3. Waist circumferences

    Time frame: Through study completion for one year, will be measured on arrival.

    Waist circumferences will be measured using a whole body laser scanner(TG2000-F).

  4. Height

    Time frame: Through study completion for one year, will be measured on arrival.

    Height will be measured by seca 217 stable stadiometer.

  5. Bone mass

    Time frame: Through study completion for one year, will be measured on arrival.

    Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).

  6. Hip circumferences

    Time frame: Through study completion for one year, will be measured on arrival.

    Hip circumferences will be measured using a whole body laser scanner(TG2000-F).

  7. Fat free mass

    Time frame: Through study completion for one year, will be measured on arrival.

    Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980) and BOD POD(COS MED,BOD POD 2020).

  8. Heart rate

    Time frame: Through study completion for one year, will be measured on arrival.

    Heart rate will be measured using an Omron sphygmomanometer.

  9. Resting energy expenditure

    Time frame: Through study completion for one year, will be measured on arrival.

    The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.

  10. Thermic effect of food

    Time frame: Through study completion for one year, will be measured on arrival.

    The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.

  11. Body shape

    Time frame: Through study completion for one year, will be measured on arrival.

    Body shape will be measured using a whole body laser scanner(TG2000-F)

  12. Fat mass

    Time frame: Through study completion for one year, will be measured on arrival.

    Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ) and BOD POD(COS MED,BOD POD 2020).

  13. Blood pressure

    Time frame: Through study completion for one year, will be measured on arrival.

    Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.

  14. Total daily water volume

    Time frame: Through study completion for one year, will be measured on arrival.

    Calculate the total amount of water to be consumed in a day by providing water cups with a graduated scale.

  15. Physical activity

    Time frame: Through study completion for one year, will be measured on arrival.

    Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 7 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.

  16. Bristol Stool Scale

    Time frame: Through study completion for one year, will be measured on arrival.

    Scoring of stool forms according to the Bristol Stool Scale, whice classified according to faecal characteristics. It has seven types. Types 1 and 2 indicate the presence of constipation, types 3 and 4 are ideal stool shapes, and types 5 to 7 represent possible diarrhoea.

  17. Total daily urine volume

    Time frame: Through study completion for one year, will be measured on arrival.

    Collect the urine sample within a day in a graduated container.

  18. Gut transit time

    Time frame: Through study completion for one year, will be measured on arrival.

    Recording the time of intake of food-grade blue pigment and the time of excretion

  19. Food macronutrient content

    Time frame: Through study completion for one year, will be measured on arrival.

    Detection of carbohydrates, proteins and fats in food by chemical analysis.

  20. Feces macronutrient content

    Time frame: Through study completion for one year, will be measured on arrival.

    Detection of carbohydrates, proteins and fats in feces by chemical analysis.

Sponsors and collaborators

Lead sponsor

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Other

Registry information

Official study title

Associations Between Gut Length, Gut Microbiota and Food Assimilation Efficiency of Healthy Individuals

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Jan 22, 2026

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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