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RecruitingNCT03221322Updated Jul 21, 2022

How do Super Lean Subjects Keep Resistant to Body Weight Gain?

An observational study in Thinness, Health Behavior and Genetics, sponsored by Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Chinese Academy of Medical Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
20 Years to 40 Years
Sex
All
01

Study summary

Obesity is the 5th leading cause of global death, and is major risk factors for many chronic diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. Obesity is caused by an imbalance between energy intake and energy expenditure, and it is widely agreed to be a consequence of a gene by environment interaction. Although on average obesity rates are increasing, the shape of the distribution of adiposity is changing: it is becoming more right skewed. This is because there is a population of very lean subjects that has remained almost unchanged by the epidemic. The investigators have called these very lean individuals that are resistant to the epidemic and sustain a BMI \< 18.5 kg/m2 'super lean' subjects. We have very little understanding of the lifestyles of these individuals and how they are able to maintain their super lean phenotype, and whether the basis of their leanness is primarily genetics.

Read the detailed description

In this study, the investigators will recruit a sample of 150 super lean healthy volunteers with a BMI >15 and \< 18.5 kg/m2 aged 20-40 years, in parallel with an age matched group of 150 healthy subjects with a BMI ≥22 and \< 25 kg/m2 as the control group. The investigators will screen out any individuals with eating disorders. In both groups, the investigators will study their lifestyles in particular focusing on their physical activity patterns and their food intake choices (monitored via food intake diaries and supported by metabolomics analyses of their urine to detect biomarkers of different food groups). Saliva samples will be collected for genotyping. The investigators will SNP genotype the individuals for 30 known polymorphic loci previously linked to obesity to establish if they have a particular genetic profile linked to their lean phenotype.

02

Conditions studied

  • Thinness
  • Health Behavior
  • Genetics
03

Who can participate

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

Study population

Participants are healthy, with no eating disorder, 25 - 35 years old in particular.

Inclusion criteria

  • control: BMI 20-25 kg/m2, healthy, age 20-40 years old superlean: BMI 15-18 kg/m2, healthy, with no eating disorders and diabetes, age 20-40 years old

Exclusion criteria

Exclusion Criteria:

  • Pregnant women and women in lactation Subjects are suffering from eating disorders or diabetes.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control

    20 kg/m2 ≤ BMI ≤ 25 kg/m2, healthy, with no eating disorder, 150 subjects, 20 - 40 years old

    Behavioral: Superlean

  • Superlean

    15 kg/m2 ≤ BMI ≤ 18 kg/m2, healthy, with no eating disorder, 150 subjects, 25 - 35 years old in particular

    Behavioral: Superlean

Interventions

  • BehavioralSuperlean

    Behavioural data will be collected on all subjects in either control group or superlean group. Blood or saliva samples will be collected for DNA extraction and genotyping.

05

What researchers measure

Primary outcomes

  1. Anthropometric measurements of participants in both control and superlean groups

    Height, waist and hip circumferences (cm) and body composition will be measured on arrival.

    Time frame: Through study completion, an average of 2 years

  2. Demographic characteristics of all participants in both control and superlean groups

    Life style questionnaire filled out on arrival.

    Time frame: Through study completion, an average of 2 years

06

Study locations

1 of 1 sites recruiting
  • Institute of Genetics and Developmental Biology
    Beijing, 100101, China
    • Sumei Hu, PhD · Contact · smhu@genetics.ac.cn · +8618500818466
    • John R Speakman, PhD · Contact · +86-10-6480-7042
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03221322
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Sumei Hu (Principal Investigator, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jul 18, 2017
Start date
Apr 6, 2017
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 21, 2022

Study contacts

John Speakman, PhD
Contact
j.speakman@abdn.ac.uk
+86-10-64807042
Sumei Hu, PhD
Contact
smhu@genetics.ac.cn
18500818466
John Speakman, PhD
principal investigator · Institute of Genetics and Developmental Biology

Oversight

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

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