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

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: Recruiting
• Conditions: Healthy Adult
• Intervention / Treatment: Dietary supplement: DNF-10: 250 mg/day; Other: Placebo: 250 mg maltodextrin/day

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28050
      • Recruiting
      • Hospital Universitario HM Sanchinarro
      • Contact: Ismael San Mauro Martín Dr.; Phone Number: +34617765977; Email: info@grupocinusa.es
      • Principal Investigator: Domingo Carrera

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of DNF-10 on dysfunctional eating behavior	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

Outcome Measure	Time Frame
Amount of food intake in response to emotional states	Baseline and after 1 month of treatment in each treatment period
Concentration of entero-hormone biomarkers	Baseline and after 1 month of treatment in each treatment period
Weight in kilograms	Baseline and after 1 month of treatment in each treatment period
Waist circumference in centimeters	Baseline and after 1 month of treatment in each treatment period

Collaborators and Investigators

• Sponsor: Fytexia
• Collaborators: Centros de Investigación de Nutrición y Salud

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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