Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10 (DNF10-APET)

June 2, 2026 updated by: Fytexia

Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10: Pilot Proof-of-concept, Crossover, Exploratory, Randomized, Double-blind, Placebo-controlled Study

This is a pilot, proof-of-concept, exploratory, randomized, double-blind, placebo-controlled crossover study. The study will be conducted in 50 healthy volunteers with a body mass index (BMI) between 18.5 and 29.9 kg/m². The objective is to comprehensively evaluate the potential of DNF-10 to modulate appetite through the regulation of enteroendocrine hormones and to determine its relevance in human physiology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
        • Principal Investigator:
          • Domingo Carrera

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women aged 20 to 50 years.
  • Body Mass Index (BMI) of 18.5-24.9 kg/m² or 25.0-29.9 kg/m².
  • Stable use of permitted medications and/or dietary supplements during the study.
  • Individuals willing to maintain their usual dietary and physical activity habits throughout the study.
  • Subjects capable of understanding and complying with the study procedures.
  • Subjects who have signed the informed consent form.

  • Female participants must meet one of the following conditions:

    1. Women with no potential for pregnancy, defined as women who have undergone surgical sterilization or who are postmenopausal.
    2. Women of childbearing potential who use a highly effective contraceptive method (hormonal contraception, intrauterine device, condoms, male partner sterilization [vasectomy], or complete sexual abstinence) while participating in the study.

Exclusion Criteria:

  • Individuals with known eating behavior disorders (verified using the Spanish version of the Adult Eating Behavior Questionnaire, AEBQ).
  • Subjects with a body weight gain or loss ≥10% within the previous 3 months.
  • Treatment with medications or dietary supplements for weight loss, satiety, or glucose control.
  • Individuals consuming protein powders or dietary supplements related to the objectives of the study.
  • Participants receiving active treatment with GLP-1 receptor agonists or similar agents.
  • Participants taking medications or dietary supplements that, in the investigator's opinion, may interfere with the study objectives (e.g., affecting appetite), pose a safety risk, or confound the interpretation of the study results.
  • Depression or anxiety disorders that affect appetite.
  • High coffee consumption (more than 4 cups per day).
  • Smokers (more than 5 cigarettes per week), smoking during study assessment days, and/or drug abuse.
  • History of bariatric surgery within the last 3 years.
  • Low iron levels requiring treatment.
  • Individuals with renal or endocrine diseases (including diabetes).
  • Untreated or unstable hyperthyroidism, suicidal ideation, bipolar disorder, or evidence of any untreated or unstable neurological disorder.
  • Conditions or diseases that, in the investigator's judgment, may be worsened by participation in the study or may jeopardize the conduct of the study.
  • Presence of infectious diseases at the time of study inclusion (participants may be included 1 month after resolution of the illness).
  • Severely immunocompromised participants (transplant recipients, individuals treated with anti-rejection medications or steroids within the previous 30 days, or those who have received chemotherapy or radiotherapy within the last year).
  • Presence of active malignancy or any concomitant end-stage organ disease within the last 12 months that, in the investigator's judgment, contraindicates participation in the study.
  • Hypersensitivity, allergy, or intolerance to any of the components of the study product or standardized study menus (e.g., cow's milk protein allergy [CMPA], celiac disease, or non-celiac gluten intolerance).
  • Current participation or participation in another clinical trial within the previous three months.
  • Pregnant or breastfeeding women, women seeking pregnancy, or women of childbearing potential who are unwilling to use an effective contraceptive method.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Placebo
Other: Placebo: 250 mg maltodextrin/day
Placebo
Experimental: Experimental
DNF-10
Dietary supplement: DNF-10: 250 mg/day
DNF-10

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with dysfunctional eating behavior
Time Frame: Baseline and after 1 month of treatment in each treatment period

The primary objective of the study is to evaluate the effect of DNF-10 on dysfunctional eating behavior in the study population compared with placebo, specifically on the frequency of:

  • unplanned eating episodes (snacking),
  • levels of food-related anxiety, and
  • the expression of emotional hunge.
Baseline and after 1 month of treatment in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Amount of food intake in response to emotional states
Time Frame: Baseline and after 1 month of treatment in each treatment period
Baseline and after 1 month of treatment in each treatment period
Concentration of entero-hormone biomarkers
Time Frame: Baseline and after 1 month of treatment in each treatment period
Baseline and after 1 month of treatment in each treatment period
Weight in kilograms
Time Frame: Baseline and after 1 month of treatment in each treatment period
Baseline and after 1 month of treatment in each treatment period
Waist circumference in centimeters
Time Frame: Baseline and after 1 month of treatment in each treatment period
Baseline and after 1 month of treatment in each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fytexia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centros de Investigación de Nutrición y Salud

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DNF10-APET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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