NCT07621393招募中不适用
Modulation of Appetite Signaling Through Enterohormone Stimulation by DNF-10: Pilot Proof-of-concept, Crossover, Exploratory, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Fytexia
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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.
排除标准
- •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.
研究者
研究点 (1)
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