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临床试验/NCT06377956
NCT06377956已完成不适用

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

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Gut length

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Gut length

时间窗: Through study completion for one year, will be measured on arrival.

Volunteers will be scanned Magnetic Resonance Imaging(Shanghai united imaging, uMR 790).

Metabolites

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John R. Speakman

Professor, chief researcher

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

研究点 (1)

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