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New treatment option for Healthy Adult
Official title Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10
ClinicalTrials.gov ID: NCT07621393
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- people capable of understanding and complying with the study procedures.
You likely can't join if
- Individuals with known eating behavior disorders (verified using the Spanish version of the Adult Eating Behavior Questionnaire, AEBQ).
- people 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...
See the full eligibility 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.
- people capable of understanding and complying with the study procedures.
- people who have signed the informed consent form.
- 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...
- Individuals with known eating behavior disorders (verified using the Spanish version of the Adult Eating Behavior Questionnaire, AEBQ).
- people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.