Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435325
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-24
Brief Title:
Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The present randomized controlled trial aims to evaluate the relationship between gene expression profiling and the response to a precision diet compared to a personalized Mediterranean-style diet control diet in metabolically healthy individuals with overweight and obesity
Compared to the control diet the precision diet is expected to increase adherence to dietary recommendations resulting in weight loss and maintenance In addition the investigators postulate that the precision diet will lead to greater lifestyle changes improving long-term well-being and health in people with overweight and obesity
Compared to the control diet the precision diet is expected to increase adherence to dietary recommendations resulting in weight loss and maintenance In addition the investigators postulate that the precision diet will lead to greater lifestyle changes improving long-term well-being and health in people with overweight and obesity
Detailed Description:
The study aims to evaluate the effectiveness of a precision diet based on gene expression versus a personalized Mediterranean-style diet For this purpose a 12-week parallel randomized controlled trial will be conducted Once eligible participants are recruited each volunteer will attend two clinical visits at baseline-week 0 T0 and week 12 T1 a study initiation visit at week 1 and three online follow-up visits at weeks 3 6 and 9
First the participants will come to the baseline visit T0 in which the investigators will collect data related to health status body composition lifestyle and well-being In addition a registered nurse will collect a blood sample for gene expression profiling along with other biochemical parameters such as glycemic and lipid markers
In the following days the biochemical results from the baseline visit will be evaluated to confirm that the volunteers are metabolically healthy For this reason it will not be until seven days after the baseline visit that the eligibility of the participants will be confirmed After this confirmation participants will be scheduled for the study initiation visit
At this visit the volunteers will be randomly assigned to one of the two study arms intervention precision diet or control diet Those assigned to the intervention arm will follow the precision diet a hypocaloric Mediterranean-style diet based on gene expression while those assigned to the control arm will follow the control diet a personalized hypocaloric Mediterranean-style diet without considering gene expression
Then 12 weeks after the start of the intervention the end of the intervention T1 will be scheduled in which the investigators will evaluate the same variables as in the baseline visit T0 In addition during the 12 weeks of the study both groups will attend three online follow-up visits every 3 weeks to ensure adherence to the intervention as well as continuous care and to adapt dietary recommendations when needed
First the participants will come to the baseline visit T0 in which the investigators will collect data related to health status body composition lifestyle and well-being In addition a registered nurse will collect a blood sample for gene expression profiling along with other biochemical parameters such as glycemic and lipid markers
In the following days the biochemical results from the baseline visit will be evaluated to confirm that the volunteers are metabolically healthy For this reason it will not be until seven days after the baseline visit that the eligibility of the participants will be confirmed After this confirmation participants will be scheduled for the study initiation visit
At this visit the volunteers will be randomly assigned to one of the two study arms intervention precision diet or control diet Those assigned to the intervention arm will follow the precision diet a hypocaloric Mediterranean-style diet based on gene expression while those assigned to the control arm will follow the control diet a personalized hypocaloric Mediterranean-style diet without considering gene expression
Then 12 weeks after the start of the intervention the end of the intervention T1 will be scheduled in which the investigators will evaluate the same variables as in the baseline visit T0 In addition during the 12 weeks of the study both groups will attend three online follow-up visits every 3 weeks to ensure adherence to the intervention as well as continuous care and to adapt dietary recommendations when needed
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