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Sponsor: TCI Co., Ltd.
Conditions: Obesity
Interventions: WM formula Group, Control group
Countries: Taiwan
The goal of this clinical trial is to evaluate the physiological effects of a WM Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The WM Formula is a multi-component dietary supplement composed of Bifidobacterium breve (Active), Rocket Apple Extract Powder (Active), Probio-kombu Black Tea Powder (Active), Soy Protein (Excipient), Gum Acacia (Excipient), and Erythritol (Excipient). Participants enrolled in the study will be required to undergo blood collection, height measurement, body composition analysis, and questionnaire completion. Each testing session will take approximately 5 hours, and participants will need to complete two trial visits in total. There will be a 7-day washout period between the two trial sessions (i.e., after completion of the first trial, the second trial will be scheduled at least 7 days later). On each trial day, blood samples and relevant assessments will be conducted at the following time points: before ingestion of the test product or placebo, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Adults aged 18 years or older who are willing to sign the informed consent form. * Body fat percentage: 30%-45% for females and 25%-40% for males, and BMI 23 - 34 kg/m2. * Non-pregnant and non-lactating women who agree to use physical contraceptive methods (e.g., condoms, intrauterine devices) throughout the study period. Exclusion Criteria: * Use of GLP-1 receptor agonists approved in Taiwan (e.g., liraglutide, semaglutide, dulaglutide), blood glucose-regulating medications, weight loss-related drugs or functional foods, probiotics, or gastrointestinal health-related supplements or medications within 30 days prior to the start of the study. * History of chronic gastrointestinal disorders, seizure disorders or epilepsy, hepatic or renal diseases, malignancies, endocrine disorders, psychiatric illnesses, alcohol or drug abuse, or other major organic diseases based on medical history. * History of gastrointestinal surgery, organ transplantation, or other major surgeries. * History of hypoglycemia. * Known lactose intolerance. * Chronic diarrhea. * Acute gastroenteritis within 2 weeks prior to study initiation. * Known allergy to any ingredient in the investigational product. * Employees or immediate family members of TCI Co., Ltd.
- Taipei, Taiwan