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The Associations Between Gut Length, Gut Microbiota and Food Assimilation

S

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Status

Completed

Conditions

Healthy Nutrition
Metabolic Syndrome, Protection Against
Food Preferences

Treatments

Other: Observation without intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06377956
SIAT-IRB-240415-H0717

Details and patient eligibility

About

The purpose of this observational study is to explore the relationships between gut length, the microbiota and food energy assimilation rates in humans.

Full 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).

Enrollment

42 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

42 participants in 1 patient group

Age between 18-40 years old, 100subjects(50 female and 50 man)
Description:
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.
Treatment:
Other: Observation without intervention

Trial contacts and locations

1

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Central trial contact

Xinrui Gao, Bachelor; John R Speakman, PhD

Data sourced from clinicaltrials.gov

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