Modulation of Appetite Signaling with DNF-10 in Healthy Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, proof-of-concept study is a randomized, double-blind, placebo-controlled crossover trial enrolling 50 healthy adults with BMI 18.5 to 29.9. Participants receive DNF-10 or placebo for a defined period and then switch to the alternate treatment, allowing within-subject comparison of appetite-related hormones and sensations. The primary goal is to characterize how DNF-10 affects enteroendocrine signaling and appetite regulation in humans. Eligibility includes adults 20-50 in good health, with stable medications and contraception as appropriate for women. Exclusion criteria include known eating disorders and other factors that could confound appetite measures. The study is led by Fytexia with collaboration from Centros de Investigación de Nutrición y Salud and is conducted at Hospital Universitario HM Sanchinarro in Madrid.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario HM Sanchinarro
  Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.