Healthy NutritionNCT06377956
The Associations Between Gut Length, Gut Microbiota and Food Assimilation
An observational study of Healthy Nutrition and Food Preferences, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition, Food Preferences, Metabolic Syndrome, Protection Against
- What is being tested?
- Observation without intervention
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 100 individuals, 50 female and 50 male
Who may be able to join
- Age between 18-40 years old, healthy and disease free.
- Regular bowel movements.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Institute of Advanced Technology
Shenzhen, Guangdong, 518055
About this study
Official title: Associations Between Gut Length, Gut Microbiota and Food Assimilation Efficiency of Healthy Individuals
The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.
Read the detailed description
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).
- Being tested
- Observation without intervention
- Keywords
- Metabolism, Microbiome/microbiota, Body composition, Food intake, Food preference
- Medical subject headings
- Food Preferences, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation without interventionOther
Observation of gut length, food intake, fecal and urine calories, body composition, microbiota, metabolic rate, metabolomics.
| Study group | Role | What they receive |
|---|---|---|
| Age between 18-40 years old, 100subjects（50 female and 50 man） | He Shuang(Polyethylene Glycol Electrolytes Powder):1/1.5 sachets of PEG(68.56-102.84g dissolved in water with1/1.5L ) were provided to volunteers based on body weight(BW): BW<60 kg, 1 sachet , BW≥60 kg, 1.5 sachets, drinking an average of 200/250 mL every 15 minutes. It will cause frequent bowel motions or diarrhoea for a couple of hours afterwards.
Raceanisodamine Hydrochloride Injection: intramuscular injection of Raceanisodamine Hydrochloride Injection with 10mg. It may cause dry mouth, red face and blurred vision. The half-life of the medicine is 40 minutes and most of the above symptoms disappear within 1 to 3 hours. Receives: Other: Observation without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut length
Volunteers will be scanned Magnetic Resonance Imaging(Shanghai united imaging, uMR 790).
Measured: Through study completion for one year, will be measured on arrival.
Energy intake
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).
Measured: Through study completion for one year, will be measured on arrival.
Fecal energy
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.
Measured: Through study completion for one year, will be measured on arrival
Microbiome/Microbiota
Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.
Measured: Through study completion for one year, will be measured on arrival.
Metabolites
Abundance of metabolites will be from metabolomic profiling of feces by LC-MS (liquid chromatography mass spectrometry).
Measured: Through study completion for one year, will be measured on arrival.
Secondary outcomes (20)
Urine energy content
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.
Measured: Through study completion for one year, will be measured on arrival.
Body weight
Volunteers will be asked to fast for 10 hours and measured fasting weight.
Measured: Through study completion for one year, will be measured on arrival.
Waist circumferences
Waist circumferences will be measured using a whole body laser scanner(TG2000-F).
Measured: Through study completion for one year, will be measured on arrival.
Height
Height will be measured by seca 217 stable stadiometer.
Measured: Through study completion for one year, will be measured on arrival.
Bone mass
Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Measured: Through study completion for one year, will be measured on arrival.
Hip circumferences
Hip circumferences will be measured using a whole body laser scanner(TG2000-F).
Measured: Through study completion for one year, will be measured on arrival.
Fat free mass
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980) and BOD POD(COS MED,BOD POD 2020).
Measured: Through study completion for one year, will be measured on arrival.
Heart rate
Heart rate will be measured using an Omron sphygmomanometer.
Measured: Through study completion for one year, will be measured on arrival.
Resting energy expenditure
The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.
Measured: Through study completion for one year, will be measured on arrival.
Thermic effect of food
The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.
Measured: Through study completion for one year, will be measured on arrival.
Body shape
Body shape will be measured using a whole body laser scanner(TG2000-F)
Measured: Through study completion for one year, will be measured on arrival.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ) and BOD POD(COS MED,BOD POD 2020).
Measured: Through study completion for one year, will be measured on arrival.
Blood pressure
Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
Measured: Through study completion for one year, will be measured on arrival.
Total daily water volume
Calculate the total amount of water to be consumed in a day by providing water cups with a graduated scale.
Measured: Through study completion for one year, will be measured on arrival.
Physical activity
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.
Measured: Through study completion for one year, will be measured on arrival.
Bristol Stool Scale
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.
Measured: Through study completion for one year, will be measured on arrival.
Total daily urine volume
Collect the urine sample within a day in a graduated container.
Measured: Through study completion for one year, will be measured on arrival.
Gut transit time
Recording the time of intake of food-grade blue pigment and the time of excretion
Measured: Through study completion for one year, will be measured on arrival.
Food macronutrient content
Detection of carbohydrates, proteins and fats in food by chemical analysis.
Measured: Through study completion for one year, will be measured on arrival.
Feces macronutrient content
Detection of carbohydrates, proteins and fats in feces by chemical analysis.
Measured: Through study completion for one year, will be measured on arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 May 2024
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Investigators
- John R Speakman, PhD, Study chair, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377956
- Sponsor's protocol ID
- SIAT-IRB-240415-H0717
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Gut Length, Gut Microbiota and Food Assimilation Efficiency of Healthy Individuals
- ClinicalTrials.gov ID
- NCT06377956
- Acronym / sponsor ID
- SIAT-IRB-240415-H0717
- Keywords
- Metabolism, Microbiome/microbiota, Body composition, Food intake, Food preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age between 18-40 years old, 100subjects（50 female and 50 man） | – | Other: Observation without interventionHe Shuang(Polyethylene Glycol Electrolytes Powder):1/1.5 sachets of PEG(68.56-102.84g dissolved in water with1/1.5L ) were provided to volunteers based on body weight(BW): BW<60 kg, 1 sachet , BW≥60 kg, 1.5 sachets, drinking an average of 200/250 mL every 15 minutes. It will cause frequent bowel motions or diarrhoea for a couple of hours afterwards. Raceanisodamine Hydrochloride Injection: intramuscular injection of Raceanisodamine Hydrochloride Injection with 10mg. It may cause dry mouth, red face and blurred vision. The half-life of the medicine is 40 minutes and most of the above symptoms disappear within 1 to 3 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 individuals, 50 female and 50 male
Key inclusion criteria (2 listed)
- Age between 18-40 years old, healthy and disease free.
- Regular bowel movements.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation without interventionObservation of gut length, food intake, fecal and urine calories, body composition, microbiota, metabolic rate, metabolomics. | Other | Age between 18-40 years old, 100subjects（50 female and 50 man） |
Primary outcome
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).
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).
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.
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.
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).
20 secondary outcomes
Urine energy content
Time frame: Through study completion for one year, will be measured on arrival.
Body weight
Time frame: Through study completion for one year, will be measured on arrival.
Waist circumferences
Time frame: Through study completion for one year, will be measured on arrival.
Height
Time frame: Through study completion for one year, will be measured on arrival.
Bone mass
Time frame: Through study completion for one year, will be measured on arrival.
Hip circumferences
Time frame: Through study completion for one year, will be measured on arrival.
Fat free mass
Time frame: Through study completion for one year, will be measured on arrival.
Heart rate
Time frame: Through study completion for one year, will be measured on arrival.
Resting energy expenditure
Time frame: Through study completion for one year, will be measured on arrival.
Thermic effect of food
Time frame: Through study completion for one year, will be measured on arrival.
Body shape
Time frame: Through study completion for one year, will be measured on arrival.
Fat mass
Time frame: Through study completion for one year, will be measured on arrival.
Blood pressure
Time frame: Through study completion for one year, will be measured on arrival.
Total daily water volume
Time frame: Through study completion for one year, will be measured on arrival.
Physical activity
Time frame: Through study completion for one year, will be measured on arrival.
Bristol Stool Scale
Time frame: Through study completion for one year, will be measured on arrival.
Total daily urine volume
Time frame: Through study completion for one year, will be measured on arrival.
Gut transit time
Time frame: Through study completion for one year, will be measured on arrival.
Food macronutrient content
Time frame: Through study completion for one year, will be measured on arrival.
Feces macronutrient content
Time frame: Through study completion for one year, will be measured on arrival.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Speakman, PhD study chair
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Nutrition and Food Preferences, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut length (time frame: Through study completion for one year, will be measured on arrival.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.