Phenotypic Characteristics of Superlean Individuals Including Gut Microbiome

NCT05804929 | Completed

• 1 other identifier: SIAT-IRB-221115-H0628
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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,

Conditions

Thinness; Health Behavior

Keywords

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

Outcome Measures

Primary Outcomes (18)

• Weight

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

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

• Height

  Height will be measured by seca 217 stable stadiometer.

  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.

  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.

  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).

  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 ).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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).

  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.

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

Study Arms (2)

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

Observation without intervention OTHER

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

Control; Superlean

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: lead

Study Sites (1)

Shenzhen Institute of Advanced Technology,

Shenzhen, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Microbial DNA was extracted from frozen fecal samples

MeSH Terms

Conditions

Thinness; Health Behavior; Food Preferences

Interventions

Observation; Methods

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: April 7, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)