The Associations Between Gut Length, Gut Microbiota and Food Assimilation

Food Preferences Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377956
• Other study ID #: SIAT-IRB-240415-H0717
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
• Contact: John R Speakman, PhD
• Phone: 15810868669
• Email: j.speakman[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

• BMI = 18.5;

• 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.

Related Conditions & MeSH terms

• Food Preferences
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against

Intervention

Other:
• Observation without intervention
Observation of gut length, food intake, fecal and urine calories, body composition, microbiota, metabolic rate, metabolomics.

Locations

Country	Name	City	State
China	Shenzhen Institute of Advanced Technology	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut length	Volunteers will be scanned Magnetic Resonance Imaging(Shanghai united imaging, uMR 790).	Through study completion for one year, will be measured on arrival.
Primary	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).	Through study completion for one year, will be measured on arrival.
Primary	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.	Through study completion for one year, will be measured on arrival
Primary	Microbiome/Microbiota	Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.	Through study completion for one year, will be measured on arrival.
Primary	Metabolites	Abundance of metabolites will be from metabolomic profiling of feces by LC-MS (liquid chromatography mass spectrometry).	Through study completion for one year, will be measured on arrival.
Secondary	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.	Through study completion for one year, will be measured on arrival.
Secondary	Body weight	Volunteers will be asked to fast for 10 hours and measured fasting weight.	Through study completion for one year, will be measured on arrival.
Secondary	Waist circumferences	Waist circumferences will be measured using a whole body laser scanner(TG2000-F).	Through study completion for one year, will be measured on arrival.
Secondary	Height	Height will be measured by seca 217 stable stadiometer.	Through study completion for one year, will be measured on arrival.
Secondary	Bone mass	Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).	Through study completion for one year, will be measured on arrival.
Secondary	Hip circumferences	Hip circumferences will be measured using a whole body laser scanner(TG2000-F).	Through study completion for one year, will be measured on arrival.
Secondary	Fat free mass	Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980) and BOD POD(COS MED,BOD POD 2020).	Through study completion for one year, will be measured on arrival.
Secondary	Heart rate	Heart rate will be measured using an Omron sphygmomanometer.	Through study completion for one year, will be measured on arrival.
Secondary	Resting energy expenditure	The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.	Through study completion for one year, will be measured on arrival.
Secondary	Thermic effect of food	The measurement of resting energy expenditure will be performed using indirect calorimetry(Whole room calorimetry) for 24h.	Through study completion for one year, will be measured on arrival.
Secondary	Body shape	Body shape will be measured using a whole body laser scanner(TG2000-F)	Through study completion for one year, will be measured on arrival.
Secondary	Fat mass	Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ) and BOD POD(COS MED,BOD POD 2020).	Through study completion for one year, will be measured on arrival.
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.	Through study completion for one year, will be measured on arrival.
Secondary	Total daily water volume	Calculate the total amount of water to be consumed in a day by providing water cups with a graduated scale.	Through study completion for one year, will be measured on arrival.
Secondary	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.	Through study completion for one year, will be measured on arrival.
Secondary	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.	Through study completion for one year, will be measured on arrival.
Secondary	Total daily urine volume	Collect the urine sample within a day in a graduated container.	Through study completion for one year, will be measured on arrival.
Secondary	Gut transit time	Recording the time of intake of food-grade blue pigment and the time of excretion	Through study completion for one year, will be measured on arrival.
Secondary	Food macronutrient content	Detection of carbohydrates, proteins and fats in food by chemical analysis.	Through study completion for one year, will be measured on arrival.
Secondary	Feces macronutrient content	Detection of carbohydrates, proteins and fats in feces by chemical analysis.	Through study completion for one year, will be measured on arrival.