💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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