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Clinical Trials/NCT06377956
NCT06377956
Completed
Not Applicable

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

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences1 site in 1 country42 target enrollmentMay 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Nutrition
Sponsor
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Enrollment
42
Locations
1
Primary Endpoint
Gut length
Status
Completed
Last Updated
3 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 15, 2024
End Date
June 30, 2025
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John R. Speakman

Professor, chief researcher

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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).

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.

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.

Secondary Outcomes

  • Waist circumferences(Through study completion for one year, will be measured on arrival.)
  • Body weight(Through study completion for one year, will be measured on arrival.)
  • Height(Through study completion for one year, will be measured on arrival.)
  • Bone mass(Through study completion for one year, will be measured on arrival.)
  • Blood pressure(Through study completion for one year, will be measured on arrival.)
  • Total daily water volume(Through study completion for one year, will be measured on arrival.)
  • Gut transit time(Through study completion for one year, will be measured on arrival.)
  • Food macronutrient content(Through study completion for one year, will be measured on arrival.)
  • Urine energy content(Through study completion for one year, will be measured on arrival.)
  • Hip circumferences(Through study completion for one year, will be measured on arrival.)
  • Heart rate(Through study completion for one year, will be measured on arrival.)
  • Fat free mass(Through study completion for one year, will be measured on arrival.)
  • Resting energy expenditure(Through study completion for one year, will be measured on arrival.)
  • Thermic effect of food(Through study completion for one year, will be measured on arrival.)
  • Body shape(Through study completion for one year, will be measured on arrival.)
  • Fat mass(Through study completion for one year, will be measured on arrival.)
  • Total daily urine volume(Through study completion for one year, will be measured on arrival.)
  • Physical activity(Through study completion for one year, will be measured on arrival.)
  • Bristol Stool Scale(Through study completion for one year, will be measured on arrival.)
  • Feces macronutrient content(Through study completion for one year, will be measured on arrival.)

Study Sites (1)

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