Clinical trial NCT05804929: Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome
Official title: Study on the Phenotype and Gut Microbiome Composition of Healthy Superlean Individuals (BMI < 18.5)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thinness
Health Behavior
Keywords: Superlean
Metabolism
Microbiome
body composition
food intake
food preference
Lead sponsor: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are healthy, with no metabolic disorder, 25 - 40 years old

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.

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

Primary outcomes:
measure: Weight
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Height
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Waist circumferences
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Hip circumferences
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Bone mineral density
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Fat mass
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Fat free mass
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Blood pressure
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Glucose
timeFrame: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
measure: Body temperature
timeFrame: Through study completion, an average of 2 years, will be measured before and after feeding.
measure: Resting energy expenditure
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Physical activity
timeFrame: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
measure: Body shape
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Energy intake
timeFrame: Through study completion, an average of 2 years, will be measured on arrival.
measure: Circulating hormones
timeFrame: Through study completion, an average of 2 years, will be measured after standard intervention meal.
measure: Microbiome
timeFrame: Through study completion, an average of 2 years, will be measured after samples collected.
measure: Metabolites
timeFrame: Through study completion, an average of 2 years, will be measured after samples collected.
measure: Genetics
timeFrame: Through study completion, an average of 2 years, will be measured after samples collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Institute of Advanced Technology,
Study officials:
References: