TCI Co., Ltd.
Taipei, Taiwan
NCT Number: NCT07097987
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Taipei, Taiwan
This study is a double-blind, single-center, crossover clinical trial in which each participant serves as their own control. The aim is to evaluate the effects of the WM Formula dietary supplement on promoting endogenous GLP-1 secretion and suppressing appetite in adults with elevated body fat percentage.
Eligible participants will be adults aged between 18 and 65 years, screened based on body fat percentage and BMI.
Inclusion criteria
Exclusion criteria
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 placebo, 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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, arabic gum (gum acacia) and erythritol.
Other names: Bifidobacterium breve, Rocket Apple extract, kombucha, soy peptide powder, arabic gum (gum acacia), erythritol
Participants in the control group will consume 50 mL water
Time frame: Day 1 and Day 7
Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Time frame: Day 1 and Day 7
Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Time frame: Day 1 and Day 7
Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
Time frame: Day 1 and Day 7
Plasma DPP-4 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7.
TCI Co., Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00445627
Body Weight, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial DetailsNCT05268042
Body Weight, Digestive System Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT01809288
Behavior, Body Weight
Bethesda, Maryland, United States
View Trial DetailsNCT00340132
Body Weight, Body Weight Changes
Phoenix, Arizona, United States
View Trial Details