- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221322
How do Super Lean Subjects Keep Resistant to Body Weight Gain?
July 19, 2022 updated by: Sumei Hu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
|
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
|
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
Time Frame: Through study completion, an average of 2 years
|
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
Time Frame: Through study completion, an average of 2 years
|
Life style questionnaire filled out on arrival.
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John Speakman, PhD, Institute of Genetics and Developmental Biology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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