ClinicalTrials.gg
CompletedNCT05804929Updated Jan 21, 2026

Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome

An observational study in Thinness and Health Behavior, sponsored by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences. Completed at 1 site in China. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
104
Ages
25 Years to 40 Years
Sex
All
01

Study 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,

Read the 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.

02

Conditions studied

  • Thinness
  • Health Behavior

Keywords

  • Superlean
  • Metabolism
  • Microbiome
  • body composition
  • food intake
  • food preference
03

In context

Thinness

66 studies on the registry are indexed under Thinness; 11 are open to participants now.

This study's enrollment of 104 is below the median of 275 across 22 observational studies indexed under Thinness.

Browse Thinness studies →

Lead sponsor

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences is the lead sponsor of 22 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants are healthy, with no metabolic disorder, 25 - 40 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
104 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control

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

    Other: Observation without intervention

  • Superlean

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

    Other: Observation without intervention

Interventions

  • OtherObservation without intervention

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

06

What researchers measure

Primary outcomes

  1. Weight

    Volunteers will be asked to fast for 10 hours and measured fasting weight.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  2. Height

    Height will be measured by seca 217 stable stadiometer.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  3. Waist circumferences

    Waist circumferences will be measured using a whole body laser scanner.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  4. Hip circumferences

    Hip circumferences will be measured using a whole body laser scanner.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  5. Bone mineral density

    Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  6. Fat mass

    Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  7. Fat free mass

    Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  8. Blood pressure

    Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  9. Glucose

    Fasting and post-prandial glucose after a standard meal will be recorded by the continuous glucose monitoring system.

    Time frame: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.

  10. Body temperature

    Body temperature will be measured before and after feeding using a thermal imaging camera.

    Time frame: Through study completion, an average of 2 years, will be measured before and after feeding.

  11. Resting energy expenditure

    The measurement of resting energy expenditure will be performed using indirect calorimetry.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  12. Physical activity

    Physical activity of the participants will be recorded using GT3X monitor for a consecutive of 7 days.

    Time frame: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.

  13. Body shape

    Body shape will be measured using a whole body laser scanner.

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  14. Energy intake

    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).

    Time frame: Through study completion, an average of 2 years, will be measured on arrival.

  15. Circulating hormones

    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.

    Time frame: Through study completion, an average of 2 years, will be measured after standard intervention meal.

  16. Microbiome

    Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.

    Time frame: Through study completion, an average of 2 years, will be measured after samples collected.

  17. Metabolites

    Abundance of metabolites will be from metabolomic profiling of serum and feces by LC-MS (liquid chromatography-mass spectrometry).

    Time frame: Through study completion, an average of 2 years, will be measured after samples collected.

  18. Genetics

    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.

    Time frame: Through study completion, an average of 2 years, will be measured after samples collected.

07

Study locations

1 site
  • Shenzhen Institute of Advanced Technology,
    Shenzhen, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05804929
Lead sponsor
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Responsible party
John R. Speakman (Professor, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences) — Principal investigator
First posted
Apr 7, 2023
Start date
Apr 1, 2023
Primary completion
May 1, 2025
Completion
May 1, 2025
Last update
Jan 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion