Healthy AdultDNF10-APETNCT07621393
Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10
A study testing DNF-10: 500 mg/day in people with Healthy Adult, run by Fytexia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- DNF-10: 500 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
Ismael San Mauro Martín Dr., +34617765977, info@grupocinusa.es
Domingo Carrera
About this study
Official title: 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.
- Conditions
- Healthy Adult
- Being tested
- DNF-10: 500 mg/day, Placebo: 500 mg maltodextrin/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNF-10: 500 mg/dayDietary supplement
DNF-10
Placebo: 500 mg maltodextrin/dayOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | DNF-10 Receives: Dietary Supplement: DNF-10: 500 mg/day |
| Control | Placebo comparator | Placebo Receives: Other: Placebo: 500 mg maltodextrin/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 1 month of treatment in each treatment period
Secondary outcomes (4)
Amount of food intake in response to emotional states
Measured: Baseline and after 1 month of treatment in each treatment period
Concentration of entero-hormone biomarkers
Measured: Baseline and after 1 month of treatment in each treatment period
Weight in kilograms
Measured: Baseline and after 1 month of treatment in each treatment period
Waist circumference in centimeters
Measured: Baseline and after 1 month of treatment in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start12 May 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centros de Investigación de Nutrición y Salud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621393
- Sponsor's protocol ID
- DNF10-APET
- Acronym
- DNF10-APET
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No