NCT07368777

Brief Summary

This study aims to compare the effects of genotype-based dietary counseling with standard dietary counseling based on general recommendations on weight loss and reduction of body fat. Participants will receive individualized dietary guidance either informed by genetic information or based on conventional dietary guidelines. Changes in body weight and body composition will be assessed over the course of the intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Dec 2025Mar 2027

Study Start

First participant enrolled

December 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 20, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

genotype-based nutritiondietary counselingweight lossnutrigenetics

Outcome Measures

Primary Outcomes (1)

  • Change in Fat Mass (%)

    Change in whole-body fat mass percentage from baseline to end of the intervention

    baseline to end of intervention (12 months)

Secondary Outcomes (2)

  • Change in Body Weight

    baseline to end of intervention (12 months)

  • Change in Lipid Profile

    baseline to end of intervention (12 months)

Study Arms (2)

Genotype-Based Dietary Counseling

EXPERIMENTAL

Participants in this arm will receive dietary counseling tailored according to their genetic profile. Dietary recommendations will be provided by qualified nutrition professionals and will be based on individual genetic information in combination with standard nutritional principles. The counseling will be delivered over the course of the intervention period.

Behavioral: Genotype-Based Dietary Counseling

Standard Dietary Counseling

ACTIVE COMPARATOR

Participants in this arm will receive dietary counseling based on general dietary guidelines and standard nutritional recommendations. Counseling will be provided by qualified nutrition professionals over the course of the intervention period, without the use of genetic information.

Behavioral: Standard Dietary Counseling

Interventions

This intervention consists of dietary counseling informed by individual genetic information. Nutrition guidance is provided by qualified nutrition professionals and aims to support weight management and reduction of body fat over the intervention period.

Also known as: Nutrigenetic dietary counseling
Genotype-Based Dietary Counseling

This intervention consists of dietary counseling based on general dietary guidelines and standard nutrition recommendations. Counseling is delivered by qualified nutrition professionals without the use of genetic information.

Also known as: General dietary recommendations
Standard Dietary Counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥18 years
  • Body mass index (BMI) ≥25 kg/m²
  • Greek-speaking (able to read and understand Greek and provide informed consent)
  • Willing and able to participate in dietary counseling and study assessments for the duration of the study

You may not qualify if:

  • Current use of pharmacological treatments for weight loss, including but not limited to GLP-1 receptor agonists, appetite suppressants, or other anti-obesity medications
  • Participation in any structured weight-loss intervention or program within the previous 3 months, including commercial weight-loss programs or medically supervised dietary interventions
  • Use of medications known to significantly affect body weight or body composition, such as systemic corticosteroids, antipsychotic medications, or medications for thyroid disorders
  • Pregnancy or lactation
  • Presence of medical conditions that may affect body weight, metabolism, or nutritional status, including untreated thyroid disease, severe gastrointestinal disorders, or endocrine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dietetics Department, School of Health Sciences, Metropolitan College

Marousi, 151 25, Greece

RECRUITING

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Angeliki Kapellou, PhD

    Dietetics Department, School of Health Sciences, Metropolitan College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 27, 2026

Study Start

December 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared outside the research team.

Locations