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OpenTrials
Completed

NCT Number: NCT06621186

Construction of an in Vitro Intestinal Microbial Ecological Simulation System for Obese People

About 2.6 billion people ( about 40 % of the world 's population ) are affected by overweight or obesity. The prevalence of overweight and obesity in Chinese adults has exceeded 50 %, and the prevalence is still on the rise.The gut microbiota is regarded as an endocrine organ and participates in energy balance. Diet changes can disrupt the relationship between the microbiota and the host, leading to metabolic diseases.Although human studies provide important information, there are limitations, such as the entry of complex gastrointestinal environment limiting components, the lack of dynamic microbial process information, and the uncertainty of drug side effects. In vitro methods can solve these problems, allowing dynamic sampling, standardized operation, high repeatability, and evaluation of potential toxins and pathogens. In vitro models are widely used to evaluate the effects on the human colon microbiome and to predict in vivo results.Based on the above research background, this study aims to collect fecal samples from obese people to construct an in vitro intestinal microbial ecological simulation system. This will lay an experimental foundation for further exploring the effect of specific nutrient intervention on the composition and function of gut microbiota in obese people.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Male

Study type

Observational

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening in the physical examination population who intend to retain fecal samples in the physical examination center of our hospital. BMI ≥ 28, age range from 18 to 30.

Exclusion criteria

  • Previous history of intestinal disease, history of hypertension, diabetes, coronary heart disease and other chronic diseases, history of important organ disease or surgery, history of malignant tumor disease.
  • He had a history of heavy smoking and alcohol abuse.
  • In the past 6 months, she took antibiotics.
  • Weight loss measures in the past 6 months, including but not limited to dieting, physical exercise, probiotic intervention and other medications.
  • Subjects and their families who disagreed with the study protocol.

Treatment and study plan

No intervention measures

Other

No intervention measures

Primary outcomes

  1. intestinal microflora

    Time frame: 2025.10

    Construction of simulated intestinal microflora ecosystem

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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