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

The Investigation of Lifestyle and Genetics in Super Lean Subjects That Keep Them Resistant to Weight Gain

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.

Study Overview

• Status: Recruiting
• Conditions: Genetics; Health Behavior; Thinness
• Intervention / Treatment: Behavioral: Superlean

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: John Speakman, PhD; Phone Number: +86-10-64807042; Email: j.speakman@abdn.ac.uk
• Study Contact Backup: Name: Sumei Hu, PhD; Phone Number: 18500818466; Email: smhu@genetics.ac.cn

Study Locations

• China
  • Beijing, China, 100101
    • Recruiting
    • Institute of Genetics and Developmental Biology
    • Contact: Sumei Hu, PhD; Phone Number: +8618500818466; Email: smhu@genetics.ac.cn
    • Contact: John R Speakman, PhD; Phone Number: +86-10-6480-7042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 20 kg/m2 ≤ BMI ≤ 25 kg/m2, healthy, with no eating disorder, 150 subjects, 20 - 40 years old	Behavioral: Superlean; 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.
Superlean; 15 kg/m2 ≤ BMI ≤ 18 kg/m2, healthy, with no eating disorder, 150 subjects, 25 - 35 years old in particular	Behavioral: Superlean; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements of participants in both control and superlean groups	Height, waist and hip circumferences (cm) and body composition will be measured on arrival.	Through study completion, an average of 2 years
Demographic characteristics of all participants in both control and superlean groups	Life style questionnaire filled out on arrival.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: John Speakman, PhD, Institute of Genetics and Developmental Biology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2017
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Thinness
• Other Study ID Numbers: 0060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No