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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435325
• Other study ID #: IIBSP-SOB-2022-109
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• 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
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI 26-35 Kg/m^2.

• Metabolically healthy.

Exclusion Criteria:

• Any comorbidity associated with obesity (such as type 2 diabetes mellitus, hypertension, dyslipidemia).

• Medications (Antidepressants; Antipsychotics; Anxiolytic; Statins; Antihypertensives; Insulin or anti-diabetics).

• Intragastric balloon or Bariatric surgery.

• History of weight loss treatment within the previous 3 months.

• Women with menopause, pregnancy, or breastfeeding.

• Smokers.

• Food allergies or intolerances.

• Eating disorders.

• Shift work.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Precision diet
After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.
• Control diet
After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.

Locations

Country	Name	City	State
Spain	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body mass index (BMI) from baseline to weeks 12 and 24.	Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2.	Week 0, 12 and 24
Primary	Changes in body fat from baseline to weeks 12 and 24.	Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).	Week 0, 12 and 24
Secondary	Changes in gene expression profiling from baseline to weeks 12 and 24.	The RNA from fasting blood samples will be sequenced using Illumina technology and then the Limma software package will be used to analyze gene expression data from the RNA sequence.	Week 0, 12 and 24
Secondary	Changes in fasting blood lipids from baseline to weeks 12 and 24.	Fasting measurement of triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.	Week 0, 12 and 24
Secondary	Changes in glycemic markers from baseline to weeks 12 and 24.	Fasting measurement of glucose, insulin, and glycated hemoglobin (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.	Week 0, 12 and 24
Secondary	Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12 and 24.	Fasting measurement of CRP will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.	Week 0, 12 and 24
Secondary	Changes in waist and hip circumference from baseline to weeks 12 and 24.	Measured to the nearest 0.1 cm using a flexible steel anthropometric tape (CESCORF, Brazil) calibrated in centimeters.	Week 0, 12 and 24
Secondary	Changes in muscle mass from baseline to weeks 12 and 24.	Measured as the kilograms of muscle mass with a body composition analyzer (Inbody 120, Korea).	Week 0, 12 and 24
Secondary	Changes in physical activity from baseline to weeks 12 and 24.	Measured in Metabolic Equivalents of Task (MET) per minute and week, using the short version of the International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions that assess the frequency, duration, and intensity of physical activity (moderate and vigorous) performed in the last seven days, as well as walking and sitting time on a workday. The minimum value is 0 MET-minutes/week, indicating no physical activity. Higher scores represent a higher amount of physical activity, while lower scores indicate lower levels of physical activity.	Week 0, 12 and 24
Secondary	Changes in energy and nutrient intake from baseline to week 24	Energy and nutrient intake will be assessed with a 151-item semi-quantitative food frequency questionnaire (FFQ) (Fernández-Ballart et al., 2010) and a 3-day dietary record (DR), in which participants will record their food intake for three days. The frequency of consumption for each food item is reported on a nine-level incremental scale (never or almost never, 1-3 times per month, once per week, 2-4 times per week, 5-6 times per week, once per day, 2-3 times per day, 4-6 times per day and more than six times per day). To calculate energy and nutrient intake from both methods (FFQ and DR), the Spanish food composition tables will be used.	Week 0, week 12, and 24
Secondary	Changes in diet quality from baseline to week 24	Diet quality will be evaluated through the 17-item Mediterranean Diet Adherence Screener (MEDAS) (Schröder et al. 2021). Score ranges from 0 to 17, where higher scores indicate greater adherence to the Mediterranean Diet.	Week 0, week 12 and 24
Secondary	Changes in eating behavior from baseline to weeks 12 and 24.	Eating behaviors will be measured with the Spanish version of the Three Factor Eating Questionnaire (TFEQ-R21) (Martín-García et al. 2016). It consists of three subscales: Cognitive Restraint (CR), Uncontrolled Eating (UE), and Emotional Eating (EE). Scores range from 0 to 21 for CR and UE, and from 0 to 15 for EE. Higher scores on each subscale indicate higher levels of the corresponding eating behavior.	Week 0, 12 and 24
Secondary	Changes in well-being from baseline to weeks 12 and 24.	Well-being will be measured with the Spanish version of the World Health Organization (WHO-5) Well-being Index (Lucas-Carrasco et. al. 2012). Scores range from 0 to 25, where higher scores indicate higher well-being.	Week 0, 12 and 24
Secondary	Changes in stress levels from baseline to week 24.	Stress will be evaluated through the Perceived Stress Scale (PSS-10), validated for Spanish population (Remor et al. 2006). Scores range from 0 to 40, where higher scores indicate a higher level of perceived stress.	Week 0 and 24
Secondary	Changes in depression and anxiety degree from baseline to week 24.	Anxiety and depression state will be measured by the Hospital Anxiety and Depression Scale (HADS), validated for Spanish population (Herrero et al. 2003). It consists of two subscales: HADS-A, designed to detect anxious states, and HADS-D, designed to detect depressive states. Scores range from o to 21, where higher scores indicate greater levels of anxiety or depression.	Week 0 and 24
Secondary	Changes in satiety from baseline to weeks 9, 16 and 24.	Satiety will be evaluated using the Visual Analogue Scale (VAS) after each meal. Scores range from 0 to 100 mm, where higher scores indicate greater levels of satiety.	Week 1, 9, 16 and 24 .