Overweight and ObesityNCT06435325
Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
A study testing Precision diet in people with Overweight and Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Precision diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 26-35 Kg/m^2.
- Metabolically healthy.
Who cannot join
- 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.
Show all 9Show fewer
- Food allergies or intolerances.
- Eating disorders.
- Shift work.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Precision diet, Control diet
- Keywords
- Personalized nutrition, Epigenetics, Metabotype, Weight Loss, Well-being
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision dietBehavioural
After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months.
Control dietBehavioural
After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Precision diet |
| Control arm | Active comparator | 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. Receives: Behavioral: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body mass index (BMI) from baseline to weeks 12.
Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2.
Measured: Week 0 and 12.
Changes in body fat from baseline to weeks 12.
Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).
Measured: Week 0 and 12.
Secondary outcomes (14)
Changes in gene expression profiling from baseline to weeks 12.
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.
Measured: Week 0 and 12.
Changes in fasting blood lipids from baseline to weeks 12.
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.
Measured: Week 0 and 12.
Changes in glycemic markers from baseline to weeks 12.
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.
Measured: Week 0 and 12.
Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12.
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.
Measured: Week 0 and 12.
Changes in waist and hip circumference from baseline to weeks 12.
Measured to the nearest 0.1 cm using a flexible steel anthropometric tape (CESCORF, Brazil) calibrated in centimeters.
Measured: Week 0 and 12.
Changes in muscle mass from baseline to weeks 12.
Measured as the kilograms of muscle mass with a body composition analyzer (Inbody 120, Korea).
Measured: Week 0 and 12.
Changes in physical activity from baseline to weeks 12.
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.
Measured: Week 0 and 12.
Changes in energy and nutrient intake from baseline to week 12.
Energy and nutrient intake will be assessed with a 151-item semi-quantitative food frequency questionnaire (FFQ) 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.
Measured: Week 0 and 12.
Changes in diet quality from baseline to week 12.
Diet quality will be evaluated through the 17-item Mediterranean Diet Adherence Screener (MEDAS). The score ranges from 0 to 17, where higher scores indicate greater adherence to the Mediterranean Diet.
Measured: Week 0 and 12.
Changes in eating behavior from baseline to weeks 12.
Eating behaviors will be measured with the Spanish version of the Three Factor Eating Questionnaire (TFEQ-R21). 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.
Measured: Week 0 and 12.
Changes in well-being from baseline to weeks 12.
Well-being will be measured with the Spanish version of the World Health Organization (WHO-5) Well-being Index. Scores range from 0 to 25, where higher scores indicate higher well-being.
Measured: Week 0 and 12.
Changes in stress levels from baseline to week 12.
Stress will be evaluated through the Perceived Stress Scale (PSS-10), validated for Spanish population. Scores range from 0 to 40, where higher scores indicate a higher level of perceived stress.
Measured: Week 0 and12.
Changes in depression and anxiety degree from baseline to week 12.
Anxiety and depression state will be measured by the Hospital Anxiety and Depression Scale (HADS), validated for Spanish population. 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.
Measured: Week 0 and 12.
Changes in satiety from baseline to weeks 9.
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.
Measured: Week 1 and 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start3 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Jose Manuel Soria, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Jose Manuel Soria, Phd, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauMaria Izquierdo-Pulido, Phd, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435325
- Sponsor's protocol ID
- IIBSP-SOB-2022-109
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
- ClinicalTrials.gov ID
- NCT06435325
- Acronym / sponsor ID
- IIBSP-SOB-2022-109
- Conditions
- Overweight and Obesity
- Keywords
- Personalized nutrition, Epigenetics, Metabotype, Weight Loss, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Precision dietThe 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. |
| Control arm | Active comparator | Behavioral: Control dietThe 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 26-35 Kg/m^2.
- Metabolically healthy.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision dietAfter the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months. | Behavioural | Intervention arm |
| Control dietAfter the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months. | Behavioural | Control arm |
Primary outcome
Changes in body mass index (BMI) from baseline to weeks 12.
Time frame: Week 0 and 12.
Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m^2.
Changes in body fat from baseline to weeks 12.
Time frame: Week 0 and 12.
Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).
14 secondary outcomes
Changes in gene expression profiling from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in fasting blood lipids from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in glycemic markers from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in waist and hip circumference from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in muscle mass from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in physical activity from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in energy and nutrient intake from baseline to week 12.
Time frame: Week 0 and 12.
Changes in diet quality from baseline to week 12.
Time frame: Week 0 and 12.
Changes in eating behavior from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in well-being from baseline to weeks 12.
Time frame: Week 0 and 12.
Changes in stress levels from baseline to week 12.
Time frame: Week 0 and12.
Changes in depression and anxiety degree from baseline to week 12.
Time frame: Week 0 and 12.
Changes in satiety from baseline to weeks 9.
Time frame: Week 1 and 9.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Related trials for Overweight and Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Manuel Soria, Phd principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Maria Izquierdo-Pulido, Phd principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision diet in people with Overweight and Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body mass index (BMI) from baseline to weeks 12. (time frame: Week 0 and 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.