Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss

Overweight and Obesity Clinical Trial

Official title: Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss

Status Recruiting

Clinical Trial 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, we postulate that the precision diet will lead to greater lifestyle changes, improving long-term well-being and health in people with overweight and obesity.

Clinical Trial 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 24-week parallel randomized controlled trial will be conducted. Once eligible participants are recruited, each volunteer will attend three clinical visits (at baseline-week 0 [T0], week 12 [T1], and week 24 [T2]), a study initiation visit (at week 1), and five online follow-up visits (at weeks 3, 6, 9, 16 and 20).

First, the participants will come to the baseline visit [T0] in which, we 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 we will schedule the second study visit [T1] in which we will evaluate the same variables as in the baseline visit [T0]. Likewise, at the end of the intervention (week 24), we will schedule the third study visit [T2] in which we will evaluate the same variables as in the baseline visit [T0].

In addition, during the 24 weeks of the study, both groups will attend five online follow-up visits (every 3 to 4 weeks) to ensure adherence to the intervention, as well as continuous care and to adapt dietary recommendations when needed. ;

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

• NCT number: NCT06435325
• Study type: Interventional
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Maria Izquiero-Pulido, Phd
• Phone: +34934037293
• Email: maria_izquierdo@ub.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Completion date: June 30, 2025