Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome

NCT ID: NCT05804929

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-05-01

Brief Summary

The goal of this observational study is to build on our previous work to further characterise the phenotype of superlean individuals (BMI < 18.5) when compared to normal BMI people (BMI 21.5 to 25). This will include characterising the body composition, food intake behaviour, circulating hormone levels, genetics and characteristics of the gut microbiota. The investigators expect to recruit up to 200 healthy superlean and control volunteers respectively,

Detailed Description

The focus of this work is to characterise the phenotype and genotype of individuals who have low BMI ( < 18.5) but are otherwise healthy and do not have eating disorders. The investigators term this group 'superlean' individuals. The study is observational and the investigators aim to establish a healthy superlean cohort,and use the combined metagenomic and metabolomic multi-omics analysis techniques, combined with imaging and physiological measurements, to focus on the correlation between gut microbiota characteristics and metabolism in superlean population. The investigators expect to recruit up to 200 healthy superlean and control volunteers (BMI 21.5 to 25) respectively, to explore the microbiota characteristics and differences between control and healthy superlean populations by measuring the basic physical indicators and metabolic parameters. This will include analyzing the postprandial hormonal changes, appetite differences, and changes in the gut microbiome and serum metabolome in the two groups of volunteers, establishing the relationship between the gut microbiota and the metabolite and metabolic phenotypes of the body, and exploring the gut microbiota.

Conditions

Thinness; Health Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

21.5≤BMI\<25, age between 25-40 years old, 200subjects.

Observation without intervention

Intervention Type: OTHER

Observation of food intake, body composition, microbiota, genetics, metabolic rate, metabolomics.

Superlean

BMI≤18.5, age between 25-40 years old, 200 subjects.

Observation without intervention

Intervention Type: OTHER

Observation of food intake, body composition, microbiota, genetics, metabolic rate, metabolomics.

Interventions

Observation without intervention

Observation of food intake, body composition, microbiota, genetics, metabolic rate, metabolomics.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Control group (21.5≤ BMI<25), Superlean group (BMI≤18.5)
• Age between 25-40 years old

Exclusion Criteria

• Having metabolic diseases or eating disorders
• Recent weight loss due to various disease causes
• Being treated for weight loss
• Having an infectious disease
• Pregnant and lactating women
• People with blood sickness, pathological hypo- or hypertension
• People suffering from claustrophobia
• No metal implants in the body
• Use of antibiotics, probiotics, oral laxatives, etc. within 8 weeks

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

John R. Speakman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shenzhen Institute of Advanced Technology,

Shenzhen, , China

Countries

China

Other Identifiers

SIAT-IRB-221115-H0628

Identifier Type: -

Identifier Source: org_study_id