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Explore the Weight Loss Effect of Amway "BODY TRIMMER"

2026年11月3日 更新者：Amway (China) R&D Center

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Principal Investigator
  • 电话号码：18018820470
  • 邮箱：shfxec@163.com

学习地点

  • 中国
      • Shanghai、中国
        • 招聘中
        • Shanghai Fengxian District Central Hospital
        • 接触：
          • Principal Investigator
          • 电话号码：18018820470
          • 邮箱：shfxec@163.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Blank control group

Subjects maintain their usual diet and daily lifestyle, and no investigational product is administered during the study period.
实验性的：Experimental group 1 (Low Dose Arm)

Amway "BODY TRIMMER", oral powder, 1 sachet administered once daily.
其他：Body trimmer intervention dose 1

Amway "BODY TRIMMER"
实验性的：Experimental group 2 (High Dose Arm)

Amway "BODY TRIMMER", oral powder, 2 sachets administered once daily.
其他：Body trimmer intervention dose 2

Amway "BODY TRIMMER"

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Weight
大体时间：baseline day 0,week4,week8,week12

Changes from weight in the high-dose, low-dose and blank control groups.
baseline day 0,week4,week8,week12

次要结果测量

结果测量
措施说明
大体时间
Blood Pressure
大体时间：baseline day 0,week4,week8,week12

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)
大体时间：baseline day 0,week4,week8,week12

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
大体时间：baseline day 0,week12

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).
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week4,week8,week12

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)
大体时间：baseline day 0,week4,week8,week12
  • 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)
大体时间：baseline day 0,week4,week8,week12
  • 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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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)
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week4,week8,week12

Waist circumference measured by soft tape measure, unit: cm.
baseline day 0,week4,week8,week12
Hip Circumference
大体时间：baseline day 0,week4,week8,week12

Hip circumference measured by soft tape measure, unit: cm.
baseline day 0,week4,week8,week12
Thigh Circumference
大体时间：baseline day 0,week4,week8,week12

Thigh circumference measured by soft tape measure, unit: cm.
baseline day 0,week4,week8,week12
Upper-arm Circumference
大体时间：baseline day 0,week4,week8,week12

Upper-arm circumference measured by soft tape measure, unit: cm.
baseline day 0,week4,week8,week12
Waist-to-Hip Ratio
大体时间：baseline day 0,week4,week8,week12

Ratio of waist circumference to hip circumference, dimensionless.
baseline day 0,week4,week8,week12

其他结果措施

结果测量
措施说明
大体时间
Changes in the Abundance of Gut Microbiota in Feces
大体时间：baseline day 0,week12

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
大体时间：baseline day 0,week12

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amway (China) R&D Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月15日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年10月15日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Amway Body Trimmer-202606CT01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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