The Associations Between Gut Length, Gut Microbiota and Food Assimilation

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.

Study Overview

• Status: Completed
• Conditions: Food Preferences; Healthy Nutrition; Metabolic Syndrome, Protection Against
• Intervention / Treatment: Other: Observation without intervention

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518055
      • Shenzhen Institute of Advanced Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

100 individuals, 50 female and 50 male

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height will be measured by seca 217 stable stadiometer.	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).	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).	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).	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).	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).	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.	Through study completion for one year, will be measured on arrival.
Heart rate	Heart rate will be measured using an Omron sphygmomanometer.	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.	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.	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)	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.	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.	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.	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.	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.	Through study completion for one year, will be measured on arrival.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
• Investigators: Study Chair: John R Speakman, PhD, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Publications and helpful links

General Publications

• WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available.
• Speakman JR, Yamada Y, Sagayama H, Berman ESF, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Creasy SA, Das SK, Cooper R, Dugas LR, Ebbeling CB, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Ludwig DS, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Melanson EL, Luke AH, Pontzer H, Rood J, Schoeller DA, Westerterp KR, Wong WW; IAEA DLW database group. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med. 2021 Feb 16;2(2):100203. doi: 10.1016/j.xcrm.2021.100203. eCollection 2021 Feb 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Body composition; Metabolism; Food intake; Food preference; Microbiome/microbiota
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Metabolic Syndrome; Food Preferences; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: SIAT-IRB-240415-H0717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No