Healthy Adult
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDNF-10: 250 mg/day
DNF-10
OTHERPlacebo: 250 mg maltodextrin/day
Placebo
Sponsors
Fytexia
Centros de Investigación de Nutrición y Salud
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with dysfunctional eating behavior | Baseline and after 1 month of treatment in each treatment period | 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. |
Secondary
| 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 |
Countries
Spain
Outcome results
None listed