ThinnessNCT05804929
Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome
An observational study of Thinness and Health Behavior, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thinness, Health Behavior
- What is being tested?
- Observation without intervention
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants are healthy, with no metabolic disorder, 25 - 40 years old
Who may be able to join
- Control group (21.5≤ BMI<25), Superlean group (BMI≤18.5)
- Age between 25-40 years old
Who cannot join
- 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
Show all 9Show fewer
- People suffering from claustrophobia
- No metal implants in the body
- Use of antibiotics, probiotics, oral laxatives, etc. within 8 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Phenotype and Gut Microbiome Composition of Healthy Superlean Individuals (BMI < 18.5)
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.
- Conditions
- Thinness, Health Behavior
- Being tested
- Observation without intervention
- Keywords
- Superlean, Metabolism, Microbiome, body composition, food intake, food preference
- Medical subject headings
- Thinness, Health Behavior, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation without interventionOther
Observation of food intake, body composition, microbiota, genetics, metabolic rate, metabolomics.
| Study group | Role | What they receive |
|---|---|---|
| Control | 21.5≤BMI<25, age between 25-40 years old, 200subjects. Receives: Other: Observation without intervention | |
| Superlean | BMI≤18.5, age between 25-40 years old, 200 subjects. Receives: Other: Observation without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Volunteers will be asked to fast for 10 hours and measured fasting weight.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Height
Height will be measured by seca 217 stable stadiometer.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Waist circumferences
Waist circumferences will be measured using a whole body laser scanner.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Hip circumferences
Hip circumferences will be measured using a whole body laser scanner.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Bone mineral density
Bone mineral density will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Fat free mass
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Blood pressure
Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Glucose
Fasting and post-prandial glucose after a standard meal will be recorded by the continuous glucose monitoring system.
Measured: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
Body temperature
Body temperature will be measured before and after feeding using a thermal imaging camera.
Measured: Through study completion, an average of 2 years, will be measured before and after feeding.
Resting energy expenditure
The measurement of resting energy expenditure will be performed using indirect calorimetry.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
Physical activity
Physical activity of the participants will be recorded using GT3X monitor for a consecutive of 7 days.
Measured: Through study completion, an average of 2 years, will be recorded for a consecutive of 7 days.
Body shape
Body shape will be measured using a whole body laser scanner.
Measured: Through study completion, an average of 2 years, will be measured on arrival.
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).
Measured: Through study completion, an average of 2 years, will be measured on arrival.
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.
Measured: Through study completion, an average of 2 years, will be measured after standard intervention meal.
Microbiome
Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.
Measured: Through study completion, an average of 2 years, will be measured after samples collected.
Metabolites
Abundance of metabolites will be from metabolomic profiling of serum and feces by LC-MS (liquid chromatography-mass spectrometry).
Measured: Through study completion, an average of 2 years, will be measured after samples collected.
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.
Measured: Through study completion, an average of 2 years, will be measured after samples collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Apr 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThinnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804929
- Sponsor's protocol ID
- SIAT-IRB-221115-H0628
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Phenotype and Gut Microbiome Composition of Healthy Superlean Individuals (BMI < 18.5)
- ClinicalTrials.gov ID
- NCT05804929
- Acronym / sponsor ID
- SIAT-IRB-221115-H0628
- Conditions
- Thinness, Health Behavior
- Keywords
- Superlean, Metabolism, Microbiome, body composition, food intake, food preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Observation without intervention21.5≤BMI<25, age between 25-40 years old, 200subjects. |
| Superlean | – | Other: Observation without interventionBMI≤18.5, age between 25-40 years old, 200 subjects. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants are healthy, with no metabolic disorder, 25 - 40 years old
Key inclusion criteria (2 listed)
- Control group (21.5≤ BMI<25), Superlean group (BMI≤18.5)
- Age between 25-40 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation without interventionObservation of food intake, body composition, microbiota, genetics, metabolic rate, metabolomics. | Other | Control, Superlean |
Primary outcome
Weight
Time frame: Through 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.
Height
Time frame: Through study completion, an average of 2 years, will be measured on arrival.
Height will be measured by seca 217 stable stadiometer.
Waist circumferences
Time frame: Through study completion, an average of 2 years, will be measured on arrival.
Waist circumferences will be measured using a whole body laser scanner.
Hip circumferences
Time frame: Through 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 density
Time frame: Through 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 mass
Time frame: Through 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 mass
Time frame: Through 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 pressure
Time frame: Through study completion, an average of 2 years, will be measured on arrival.
Systolic and diastolic blood pressure will be measured using an Omron sphygmomanometer.
Glucose
Time frame: Through 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 temperature
Time frame: Through 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 expenditure
Time frame: Through 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 activity
Time frame: Through 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 shape
Time frame: Through study completion, an average of 2 years, will be measured on arrival.
Body shape will be measured using a whole body laser scanner.
Energy intake
Time frame: Through 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 hormones
Time frame: Through 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.
Microbiome
Time frame: Through 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.
Metabolites
Time frame: Through 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).
Genetics
Time frame: Through 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thinness and Health Behavior, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Through study completion, an average of 2 years, will be measured on arrival.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.