The Role of Genetics in Weight Loss (GENEROOS)

University of Helsinki

Status: Completed

Conditions: Body Mass Index (BMI)

Treatments: Behavioral: Diet intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT06092372

945733HUS5832022

Details and patient eligibility

About

The prevalence of both overweight and obesity is increasing at an alarming rate worldwide. In fact, it is estimated that 2.16 billion adults (38%) will be overweight and 1.12 billion adults (20%) will be obese by 2030. Among other risk factors (e.g., 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 high/low 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%; n=600) and very low (Bottom 5%; n=600) PS for BMI. Half of the participants in each group will be subsequently randomized to enroll in a dietary/lifestyle 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.

Enrollment: 223 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 30-65 years old
• body mass index (BMI) of 25-35
• participants with genetic data available
• participants with a valid recontacting informed consent to their biobank

Exclusion criteria

• diagnosis of type I and II Diabetes Mellitus
• history of bariatric surgery
• diagnosis of schizophrenia and intellectual disability
• diagnosis of dementia and Parkinson's
• diagnosis of visual impairment
• diagnosis of multiple sclerosis
• pregnancy or breastfeeding during enrollment screening

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in the control group will be asked to fill out online surveys and book appointments for blood sample collection and weight measurements at the beginning and at the end of the study. In addition, participants will be asked to report their weight two more times during the study (in months 2 and 4) with an online survey that will be sent via the MyBiobank portal. The participation in the study ends with another personal visit to the clinic for blood sampling and weight measurement six months after registration. No other personal advice or support is provided to this group.

Diet Intervention

Experimental group

Description:

Participants in the diet intervention group will be asked to fill out online surveys and book appointments for blood sample collection and weight measurements at the beginning and at the end of the study. After visiting the clinic for the first time, each participant will be contacted to start a diet coaching program and to obtain an activity tracking device. In addition, each participant will be asked to report their weight two more times during the study (in months 2 and 4) with an online survey that will be sent to them via the online portal of the study (OmaBiopankki portal). The study participation ends with another personal visit to the clinic for blood sampling and weight measurement six months after registration.

Treatment:

Behavioral: Diet intervention program