Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10

NCT07621393 | Recruiting DMC

• 1 other identifier: DNF10-APET
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (1)

• Number of Participants with 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 Outcomes (4)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

DNF-10

Dietary Supplement: DNF-10: 250 mg/day

Control

PLACEBO COMPARATOR

Placebo

Other: Placebo: 250 mg maltodextrin/day

Interventions

DNF-10: 250 mg/day DIETARY_SUPPLEMENT

DNF-10

Experimental

Placebo: 250 mg maltodextrin/day OTHER

Placebo

Control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Women with no potential for pregnancy, defined as women who have undergone surgical sterilization or who are postmenopausal.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Fytexia: lead
• Centros de Investigación de Nutrición y Salud: collaborator

Study Sites (1)

Hospital Universitario HM Sanchinarro

Madrid, Madrid, 28050, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 2, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)