Evaluation of the Efficacy of the Composite WM Formula in Promoting GLP-1 Secretion
NCT ID: NCT07097987
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
14 participants
INTERVENTIONAL
2025-08-31
2025-12-31
Brief Summary
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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 water, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.
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Detailed Description
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Eligible participants will be adults aged 18 years or older, screened based on body fat percentage.
Inclusion criteria:
-Body fat percentage ≥30% for females or ≥25% for males.
Exclusion criteria:
* Prior use of GLP-1 receptor agonists approved in Taiwan (e.g., liraglutide, semaglutide, dulaglutide),
* Use of blood glucose-regulating medications,
* Presence of major organic diseases, Or a history of hypoglycemia.
After enrollment, participants will be required to visit TCI Co., Ltd. for blood collection, height and body composition measurements, and completion of questionnaires. Each study visit will take approximately 5 hours, and participants will undergo two test sessions, separated by a 7-day washout period (i.e., after completing the first test, the second will occur at least 7 days later).
On each test day, blood samples (\~14 mL per time point) will be collected via an indwelling venous catheter at the following time points: before ingestion of the test product or water, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion. The blood samples will be analyzed for GLP-1, DPP-4, complete blood count (CBC), blood glucose, and insulin concentrations.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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No Intervention: Control group
Participants in the control group will consume 50 mL water
Control group
Participants in the control group will consume 50 mL water
Experimental: WM formula Group
Participants in the intervention group will consume a single dose of WM formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract.
WM formula Group
Participants in the intervention group will consume a single dose of WM formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. The ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol.
Interventions
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WM formula Group
Participants in the intervention group will consume a single dose of WM formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. The ClpB formula consists of kombucha, soy peptide powder, L-arabinose and erythritol.
Control group
Participants in the control group will consume 50 mL water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body fat percentage: ≥30% for females and ≥25% for males.
* Non-pregnant and non-lactating women who agree to use physical contraceptive methods (e.g., condoms, intrauterine devices) throughout the study period.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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TCI Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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TCI Co., Ltd.
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-048-A
Identifier Type: -
Identifier Source: org_study_id
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