## Protocol Section
### Identification Module
**NCT ID:** NCT06435325

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

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

#### Organization Study ID Info
**ID:** IIBSP-SOB-2022-109
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Barcelona

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

#### Responsible Party

**Investigator Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

**Investigator Full Name:** Jose Manuel Soria

**Investigator Title:** Director of the Genomics Unit in Complex Diseases

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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, 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.

**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 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.

### Conditions Module

**Conditions:**

- Overweight and Obesity

**Keywords:**

- Personalized nutrition

- Epigenetics

- Metabotype

- Weight Loss

- Well-being

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 61

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The intervention arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) with dietary recommendations based on the participant's gene expression profile.

**Intervention Names:**

- Behavioral: Precision diet

**Label:** Intervention arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) personalized to the participant's dietary and lifestyle habits.

**Intervention Names:**

- Behavioral: Control diet

**Label:** Control arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention arm

**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.

**Name:** Precision diet

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control arm

**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.

**Name:** Control diet

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m\^2.

**Measure:** Changes in body mass index (BMI) from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).

**Measure:** Changes in body fat from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

#### Secondary Outcomes

**Description:** 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.

**Measure:** Changes in gene expression profiling from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** 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.

**Measure:** Changes in fasting blood lipids from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** 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.

**Measure:** Changes in glycemic markers from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** 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.

**Measure:** Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Measured to the nearest 0.1 cm using a flexible steel anthropometric tape (CESCORF, Brazil) calibrated in centimeters.

**Measure:** Changes in waist and hip circumference from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Measured as the kilograms of muscle mass with a body composition analyzer (Inbody 120, Korea).

**Measure:** Changes in muscle mass from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Measured in Metabolic Equivalents of Task (METs) using the short version of the International Physical Activity Questionnaire (IPAQ).

**Measure:** Changes in physical activity from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Energy and nutrient intake will be assessed with a 151-item semi-quantitative food frequency questionnaire (Fernández-Ballart et al., 2010) and a 3-day dietary record.

**Measure:** Changes in energy and nutrient intake from baseline to week 24

**Time Frame:** Week 0 and 24

**Description:** Diet quality will be evaluated through the 17-item Mediterranean Diet Adherence Screener (MEDAS) (Schröder et al. 2021).

**Measure:** Changes in diet quality from baseline to week 24

**Time Frame:** Week 0 and 24

**Description:** Eating behaviors (emotional eating, uncontrolled eating and cognitive restraint) will be measured with the Spanish version of the Three Factor Eating Questionnaire (TFEQ-R21) (Martín-García et al. 2016).

**Measure:** Changes in eating behavior from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Well-being will be measured with the Spanish version of the World Health Organization (WHO-5) Well-being Index (Lucas-Carrasco et. al. 2012).

**Measure:** Changes in well-being from baseline to weeks 12 and 24.

**Time Frame:** Week 0, 12 and 24

**Description:** Stress will be evaluated through the Perceived Stress Scale (PSS-10), validated for Spanish population (Remor et al. 2006).

**Measure:** Changes in stress levels from baseline to week 24.

**Time Frame:** Week 0 and 24

**Description:** 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.

**Measure:** Changes in depression and anxiety degree from baseline to week 24.

**Time Frame:** Week 0 and 24

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** maria_izquierdo@ub.edu

**Name:** Maria Izquiero-Pulido, Phd

**Phone:** +34934037293

**Role:** CONTACT

**Contact 2:**

**Email:** iparillim@ub.edu

**Name:** Isabella Parilli-Moser, Phd

**Phone:** +34638793344

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Email:** maria_izquierdo@ub.edu

- **Name:** Maria Izquierdo Pulido, Phd

- **Phone:** +34934037293

- **Role:** CONTACT

**Country:** Spain

**Facility:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

**Status:** RECRUITING

**Zip:** 08041

#### Overall Officials

**Official 1:**

**Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

**Name:** Jose Manuel Soria, Phd

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Barcelona

**Name:** Maria Izquierdo-Pulido, Phd

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000001836

- Term: Body Weight Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-31
