Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10

ConditionHealthy Adult

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-50

SponsorFytexia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

DNF-10: 250 mg/day
Dietary supplement
DNF-10
Placebo: 250 mg maltodextrin/day
Other intervention
Placebo

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame