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Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome

Study on the Phenotype and Gut Microbiome Composition of Healthy Superlean Individuals (BMI < 18.5)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804929
Enrollment
104
Registered
2023-04-07
Start date
2023-04-01
Completion date
2025-05-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior, Thinness

Keywords

Superlean, Metabolism, Microbiome, body composition, food intake, food preference

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.

Interventions

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

Sponsors

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
WeightThrough study completion, an average of 2 years, will be measured on arrival.Volunteers will be asked to fast for 10 hours and measured fasting weight.
HeightThrough study completion, an average of 2 years, will be measured on arrival.Height will be measured by seca 217 stable stadiometer.
Waist circumferencesThrough study completion, an average of 2 years, will be measured on arrival.Waist circumferences will be measured using a whole body laser scanner.
Hip circumferencesThrough study completion, an average of 2 years, will be measured on arrival.Hip circumferences will be measured using a whole body laser scanner.
Bone mineral densityThrough study completion, an average of 2 years, will be measured on arrival.Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Fat massThrough study completion, an average of 2 years, will be measured on arrival.Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Fat free massThrough study completion, an average of 2 years, will be measured on arrival.Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).
Blood pressureThrough study completion, an average of 2 years, will be measured on arrival.Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
GlucoseThrough study completion, an average of 2 years, will be recorded for a consecutive of 7 days.Fasting and post-prandial glucose after a standard meal will be recorded by the continuous glucose monitoring system.
Body temperatureThrough study completion, an average of 2 years, will be measured before and after feeding.Body temperature will be measured before and after feeding using a thermal imaging camera.
Resting energy expenditureThrough study completion, an average of 2 years, will be measured on arrival.The measurement of resting energy expenditure will be performed using indirect calorimetry.
Physical activityThrough study completion, an average of 2 years, will be recorded for a consecutive of 7 days.Physical activity of the participants will be recorded using GT3X monitor for a consecutive of 7 days.
Body shapeThrough study completion, an average of 2 years, will be measured on arrival.Body shape will be measured using a whole body laser scanner.
Energy intakeThrough study completion, an average of 2 years, 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).
Circulating hormonesThrough study completion, an average of 2 years, will be measured after standard intervention meal.Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.
MicrobiomeThrough study completion, an average of 2 years, will be measured after samples collected.Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.
MetabolitesThrough study completion, an average of 2 years, will be measured after samples collected.Abundance of metabolites will be from metabolomic profiling of serum and feces by LC-MS (liquid chromatography-mass spectrometry).
GeneticsThrough study completion, an average of 2 years, will be measured after samples collected.Polymorphic variation will be assessed in a panel of SNPs (single nucleotide polymorphism) previously linked to body composition and physical activity using a Mass array sequencer.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026