NCT06435325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

June 3, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 4, 2025

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

May 24, 2024

Last Update Submit

April 2, 2025

Conditions

Overweight and Obesity

Keywords

Personalized nutritionEpigeneticsMetabotypeWeight LossWell-being

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Week 0 and 12.

Secondary Outcomes (14)

  • Changes in gene expression profiling from baseline to weeks 12.

    Week 0 and 12.

  • Changes in fasting blood lipids from baseline to weeks 12.

    Week 0 and 12.

  • Changes in glycemic markers from baseline to weeks 12.

    Week 0 and 12.

  • Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12.

    Week 0 and 12.

  • Changes in waist and hip circumference from baseline to weeks 12.

    Week 0 and 12.

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Control diet

Interventions

Precision dietBEHAVIORAL

After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months.

Intervention arm
Control dietBEHAVIORAL

After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 3-months.

Control arm

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 26-35 Kg/m\^2.
  • Metabolically healthy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Jose Manuel Soria, Phd

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

    PRINCIPAL INVESTIGATOR

  • Maria Izquierdo-Pulido, Phd

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Genomics Unit in Complex Diseases

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

June 3, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 4, 2025

Record last verified: 2024-07

Locations

ES(1)