Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06092372
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2023-10-11
Brief Title:
The Role of Genetics in Weight Loss
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
The Role of Genetics in Weight Loss a Randomized Diet Intervention Study in Individuals With High or Low Genetic Risk for Obesity GENEROOS Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENEROOS
Brief Summary:
The prevalence of both overweight and obesity is increasing at an alarming rate worldwide In fact it is estimated that 216 billion adults 38 will be overweight and 112 billion adults 20 will be obese by 2030 Among other risk factors eg environmental behavioral and medical genetics holds an important role Genome-wide association studies have discovered hundreds of loci associated with body mass index BMI Polygenic scores PS are generated from a combination of millions of genetic variants that are associated with BMI Several diet intervention studies aimed at reducing body weight in overweight and obese individuals However the effect of genetic background on the effectiveness of diet interventions is largely unknown To our knowledge the Diet Intervention Examining The Factors Interacting with Treatment Success DIETFITS trial is the only prospective study that has been designed to evaluate the effect of genotypes in modifying the impact of a healthy low-fat diet vs a healthy low-carbohydrate diet on weight change but this study did not consider PS
The aim of our study is to determine whether BMI PS impacts the effectiveness of dietary intervention in reducing BMI among individuals with elevated BMI
To achieve this the investigators will leverage the unique opportunity provided by the Finnish biobanks research environment to re-contact 1200 individuals who have extreme genetic predisposition for highlow BMI as measured by a PS for BMI and evaluate how a randomized diet intervention effect varies between the two extreme groups In brief the investigators will invite overweight 25-35 BMI individuals with very high Top 5 n600 and very low Bottom 5 n600 PS for BMI Half of the participants in each group will be subsequently randomized to enroll in a dietarylifestyle coaching intervention program or the placebo group and not receive any dietary advice or information All participants will be asked to answer an online questionnaire and provide a fasting blood sample at baseline and at the end of the study
This well-powered prospective study leverages the unique opportunity to re-contact individuals at the extremes of BMI PS from a large pool of individuals with already available genetic information This study will determine whether BMI PS can be used to identify overweight and obese individuals who are more likely to succeed in a reduced-energy dietary intervention which will assist our efforts in curbing the overweight and obesity epidemic
The aim of our study is to determine whether BMI PS impacts the effectiveness of dietary intervention in reducing BMI among individuals with elevated BMI
To achieve this the investigators will leverage the unique opportunity provided by the Finnish biobanks research environment to re-contact 1200 individuals who have extreme genetic predisposition for highlow BMI as measured by a PS for BMI and evaluate how a randomized diet intervention effect varies between the two extreme groups In brief the investigators will invite overweight 25-35 BMI individuals with very high Top 5 n600 and very low Bottom 5 n600 PS for BMI Half of the participants in each group will be subsequently randomized to enroll in a dietarylifestyle coaching intervention program or the placebo group and not receive any dietary advice or information All participants will be asked to answer an online questionnaire and provide a fasting blood sample at baseline and at the end of the study
This well-powered prospective study leverages the unique opportunity to re-contact individuals at the extremes of BMI PS from a large pool of individuals with already available genetic information This study will determine whether BMI PS can be used to identify overweight and obese individuals who are more likely to succeed in a reduced-energy dietary intervention which will assist our efforts in curbing the overweight and obesity epidemic
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None