Precision Lifestyle Intervention and Anthropometric, Nutritional, and Metabolic Health Outcomes

NCT07450066 | Completed

• 1 other identifier: 3736/18mPI
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to recruit a core cohort of adults with normal weight, overweight, and obesity, but without other metabolic alterations, to undergo a six-month nutritional intervention. The main objective is to compare a genotype- and phenotype-based nutrition approach with a traditional nutrition plan adjusted only to phenotype. To evaluate the effectiveness of each type of intervention, anthropometric measurements and nutritional assessments will be collected at baseline, three months, and six months. In addition, plasma samples will be obtained to analyze clinical and non-clinical biomarkers, providing a more comprehensive evaluation of health status at baseline and after six months of intervention.

Conditions

Obesity & Overweight

Keywords

personalized nutrition; nutrigenetics; biomarkers; obesity; overweight

Outcome Measures

Primary Outcomes (2)

• Body Mass Index

  BMI will be calculated from body weight and height using the formula: BMI = weight (kg) / height (m)²

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

• Body Fat Percentage

  Body fat (%) will be assessed by bioelectrical impedance analysis (BIA)

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

Secondary Outcomes (28)

• Body Weight

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

• Waist Circumference

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

• Hip Circumferenc

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

• CUN-BAE

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

• Waist-to-hip ratio

  Baseline, Month 3 of intervention, Month 6 (end) of intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants assigned to this arm (initially comprising 50 individuals) received nutritional counseling to promote adherence to a standard Mediterranean diet, based on general healthy eating guidelines for the Spanish adult population, along with phenotype-tailored recommendations for physical activity.

Other: Diet

Personalized Nutrition

EXPERIMENTAL

Participants in this arm were advised to follow a Mediterranean diet adapted through nutritional and physical activity recommendations tailored to their genetic profile, developed on the basis of a commercial nutrigenetic report.

Other: Diet

Interventions

Diet OTHER

A six-month intervention consisting of lifestyle counseling aimed at promoting adherence to a standard Mediterranean diet and providing phenotype-tailored physical activity recommendations.

Control

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of the Balearic Islands: lead

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: October 27, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)