Explore the Weight Loss Effect of Amway "BODY TRIMMER"

A Prospective, Parallel-Controlled Clinical Trial to Explore the Weight Loss Effect of Amway "BODY TRIMMER" on Study Participants With Abdominal Obesity

The goal of this clinical trial is to explore the weight loss effect of Amway "BODY TRIMMER" on study participants with abdominal obesity. The main questions it aim to answer is:

Does Amway "BODY TRIMMER" reduce the weight of Study participants? Researchers will compare both high and low dosage groups (after taking Amway "BODY TRIMMER" ) to observe the improvement of weight loss indicators in abdominal obesity.

Participants will:

Take Amway "BODY TRIMMER" every day for 3 months. Regularly report on three meals. Visit the clinic once every 4 weeks for checkups and tests.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Obesity
• Intervention / Treatment: Other: Body trimmer intervention dose 1; Other: Body trimmer intervention dose 2

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 18018820470; Email: shfxec@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Fengxian District Central Hospital
    • Contact: Principal Investigator; Phone Number: 18018820470; Email: shfxec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female participants aged 30 to 65 years (inclusive), with an equal male-to-female enrollment ratio.
• Presence of abdominal obesity, defined as: waist circumference ≥90 cm in males or ≥85 cm in females; or waist-to-hip ratio (WHR) ≥0.90 in males or ≥0.85 in females.
• Body mass index (BMI) ≥24.0 kg/m².
• No use of any prescription drugs, over-the-counter medications, traditional Chinese medicines, or health supplements that may affect blood pressure, lipid profile, glucose metabolism, endocrine function, or intestinal microbiota within 1 month prior to screening.
• No documented history of allergy or intolerance to any components of the investigational product.
• Able to fully understand the study objectives, procedures, and potential adverse reactions, voluntarily provides written informed consent, and is willing and able to complete the 12-week intervention and scheduled follow-up assessments.

Exclusion Criteria:

• A history of clinically significant hepatic or renal dysfunction (mild simple non-alcoholic fatty liver disease is excluded), untreated or managed thyroid disorders including hyperthyroidism and hypothyroidism, or any cardiovascular or cerebrovascular disease requiring ongoing medical intervention.
• Diagnosis of any chronic or active gastrointestinal or intestinal disease within 1 year prior to screening (e.g., chronic diarrhea, chronic constipation), regardless of disease status at enrollment.
• Use of any weight-loss interventions within 3 months before screening, including weight-loss prescription drugs, over-the-counter products, traditional Chinese medicines, oral or injectable health supplements, or weight-loss devices. Examples include but are not limited to: semaglutide, liraglutide, phentermine, orlistat, amylase inhibitors, L-carnitine preparations, prebiotic enzyme supplements, and chitosan capsules.
• Screening laboratory values showing total cholesterol (TC) >10.34 mmol/L or triglycerides (TG) >5.7 mmol/L.
• Excessive alcohol consumption, defined as a weekly pure alcohol intake exceeding 210 g in males or 140 g in females (referencing the 2024 Guidelines for the Prevention and Treatment of Metabolic-Associated Fatty Liver Disease).
• Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening (without antihypertensive medication).
• Known allergy or hypersensitivity to any ingredients of the investigational product.
• Pregnancy or breastfeeding status at screening.
• Participants or their partners with a planned pregnancy, sperm donation, or egg donation from the time of informed consent through 3 months after the final study product administration, who are unwilling to practice effective non-study contraception during this period.
• Any form of intentional dietary restriction undertaken from 30 days prior to informed consent up to the enrollment day.
• Presence of psychiatric disorders or any other medical or social conditions deemed inappropriate for study participation by the investigator's clinical judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Blank control group; Subjects maintain their usual diet and daily lifestyle, and no investigational product is administered during the study period.
Experimental: Experimental group 1 (Low Dose Arm); Amway "BODY TRIMMER", oral powder, 1 sachet administered once daily.	Other: Body trimmer intervention dose 1; Amway "BODY TRIMMER"
Experimental: Experimental group 2 (High Dose Arm); Amway "BODY TRIMMER", oral powder, 2 sachets administered once daily.	Other: Body trimmer intervention dose 2; Amway "BODY TRIMMER"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Changes from weight in the high-dose, low-dose and blank control groups.	baseline day 0,week4,week8,week12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Between-group changes across the high-dose group, low-dose group, and blank control group at baseline, 4-week, 8-week, and 12-week follow-up; within-group changes in the high-dose group and low-dose group from baseline to 12-week follow-up. Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.	baseline day 0,week4,week8,week12
BMI (Body Mass Index)	Between-group changes across the high-dose group, low-dose group, and blank control group at baseline, 4-week, 8-week, and 12-week follow-up; within-group changes in the high-dose group and low-dose group from baseline to 12-week follow-up.	baseline day 0,week4,week8,week12
Improvement of Fat and Muscle Portions and Body Fat Percentage measured by Inbody S10 or S770 from baseline	Body composition consists of specific body components including fat, protein, minerals and body water measured by Inbody S10 or S770.Within-group changes in the high-dose group and low-dose group from baseline to 12-week follow-up; between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Changes from baseline in abdominal fat (Android fat % and Gynoid fat %) measured by dual-energy X-ray absorptiometry (DXA).	Within-group changes in the high-dose group and low-dose group from baseline to 12-week follow-up; between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Blood Lipids	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Blood Glucose	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Serum Insulin	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
C-reactive protein (CRP)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
1L-6	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Glycated Hemoglobin (HbA1c)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Appetite Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) The VAS was used to assess satiety, with scores ranging from 0 to 30 points.; 0-10 points: Good satiety: moderate appetite, weak hunger sensation, low food intake, favorable for weight loss; 11-20 points: Moderate satiety: balanced appetite and hunger, normal food intake, generally controllable; 21-30 points: Poor satiety: strong appetite, intense hunger sensation, large food intake, unfavorable for weight loss	baseline day 0,week4,week8,week12
Dietary Pattern and Fat Intake Assessment (total score: 10-40 points)	35-40 points: Excellent diet Regular and healthy dietary pattern, low oil and sugar intake, sufficient vegetable consumption, limited high-fat foods; 28-34 points: Good diet Generally healthy diet; fat and snack intake are manageable; 20-27 points: Fair diet Relatively high fat intake; frequent take-out meals and snacks; dietary adjustments are needed; 10-19 points: Poor diet High-oil and high-sugar diet; frequent take-out and fried foods; major barriers to weight loss	baseline day 0,week4,week8,week12
Physical Activity Assessment (total score: 3-12 points)	10-12 points: Excellent physical activity Regular exercise with adequate duration and high daily activity level; 7-9 points: Good physical activity Established exercise habits; activity levels meet requirements; 5-6 points: Fair physical activity Occasional exercise; predominantly sedentary daily lifestyle; 3-4 points: Poor physical activity Virtually no exercise; prolonged sedentary behavior; insufficient energy expenditure	baseline day 0,week4,week8,week12
Alanine Aminotransferase (ALT)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Aspartate Aminotransferase (AST)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Alkaline Phosphatase (ALP)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Gamma-Glutamyl Transferase (GGT)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Total Bilirubin (TBIL)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Direct Bilirubin (DBIL)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Total Protein (TP)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Uric Acid	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Serum Creatinine (Scr)	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Serum Urea	Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.	baseline day 0,week12
Waist Circumference	Waist circumference measured by soft tape measure, unit: cm.	baseline day 0,week4,week8,week12
Hip Circumference	Hip circumference measured by soft tape measure, unit: cm.	baseline day 0,week4,week8,week12
Thigh Circumference	Thigh circumference measured by soft tape measure, unit: cm.	baseline day 0,week4,week8,week12
Upper-arm Circumference	Upper-arm circumference measured by soft tape measure, unit: cm.	baseline day 0,week4,week8,week12
Waist-to-Hip Ratio	Ratio of waist circumference to hip circumference, dimensionless.	baseline day 0,week4,week8,week12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Abundance of Gut Microbiota in Feces	Changes and differences at 12-week follow-up.To investigate changes in the relative abundance of microbial communities as determined by 16S rRNA sequencing analysis and differences in the absolute abundance of specific microbial communities as determined by qPCR quantification	baseline day 0,week12
Changes in Metabolic Byproducts in Feces	Changes and differences at 12-week follow-up. Quantitative analysis of fecal metabolites including lactic acid, palmitoylcarnitine, glutamine, and oleoylcarnitine is performed using ultra-high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).	baseline day 0,week12

Collaborators and Investigators

• Sponsor: Amway (China) R&D Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: October 15, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Abdominal
• Other Study ID Numbers: Amway Body Trimmer-202606CT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No