Clinical trial NCT06377956: The Associations Between Gut Length, Gut Microbiota and Food Assimilation
Official title: Associations Between Gut Length, Gut Microbiota and Food Assimilation Efficiency of Healthy Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Nutrition
Food Preferences
Metabolic Syndrome, Protection Against
Keywords: Metabolism
Microbiome/microbiota
Body composition
Food intake
Food preference
Lead sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 individuals, 50 female and 50 male

Brief summary: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Gut length
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Energy intake
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Fecal energy
timeFrame: Through study completion for one year, will be measured on arrival
measure: Microbiome/Microbiota
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Metabolites
timeFrame: Through study completion for one year, will be measured on arrival.
Secondary outcomes:
measure: Urine energy content
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Body weight
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Waist circumferences
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Height
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Bone mass
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Hip circumferences
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Fat free mass
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Heart rate
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Resting energy expenditure
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Thermic effect of food
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Body shape
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Fat mass
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Blood pressure
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Total daily water volume
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Physical activity
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Bristol Stool Scale
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Total daily urine volume
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Gut transit time
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Food macronutrient content
timeFrame: Through study completion for one year, will be measured on arrival.
measure: Feces macronutrient content
timeFrame: Through study completion for one year, will be measured on arrival.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Institute of Advanced Technology
state: Guangdong
Study officials:
affiliation: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
name: John R Speakman, PhD
role: STUDY_CHAIR
References: