- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368777
Comparison of Genotype-Based Dietary Counseling Versus Standard Dietary Counseling on Weight Loss and Fat Mass Reduction
January 26, 2026 updated by: Angeliki Kapellou, Metropolitan College
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Angeliki Kapellou, PhD
- Phone Number: +30 6938406218
- Email: akapellou@mitropolitiko.edu.gr
Study Locations
-
-
-
Marousi, Greece, 151 25
- Recruiting
- Dietetics Department, School of Health Sciences, Metropolitan College
-
Contact:
- Angeliki Kapellou, PhD
- Phone Number: +30 21 3333 0300
- Email: akapellou@mitropolitiko.edu.gr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Genotype-Based Dietary Counseling
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.
|
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.
Other Names:
|
|
Active Comparator: Standard Dietary Counseling
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fat Mass (%)
Time Frame: baseline to end of intervention (12 months)
|
Change in whole-body fat mass percentage from baseline to end of the intervention
|
baseline to end of intervention (12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: baseline to end of intervention (12 months)
|
Change in body weight from baseline to end of the intervention
|
baseline to end of intervention (12 months)
|
|
Change in Lipid Profile
Time Frame: baseline to end of intervention (12 months)
|
Change in fasting lipid profile parameters (e.g., total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of the intervention.
|
baseline to end of intervention (12 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angeliki Kapellou, PhD, Dietetics Department, School of Health Sciences, Metropolitan College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
January 20, 2026
First Submitted That Met QC Criteria
January 20, 2026
First Posted (Actual)
January 27, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared outside the research team.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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