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Explore the Weight Loss Effect of Amway "BODY TRIMMER"

3 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

110

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Principal Investigator
  • Telefoonnummer: 18018820470
  • E-mail: shfxec@163.com

Studie Locaties

  • China
      • Shanghai, China
        • Werving
        • Shanghai Fengxian District Central Hospital
        • Contact:
          • Principal Investigator
          • Telefoonnummer: 18018820470
          • E-mail: shfxec@163.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Blank control group

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

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

Amway "BODY TRIMMER"
Experimenteel: Experimental group 2 (High Dose Arm)

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

Amway "BODY TRIMMER"

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weight
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood Pressure
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline day 0,week4,week8,week12

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

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

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

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in the Abundance of Gut Microbiota in Feces
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Amway (China) R&D Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 oktober 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

15 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

9 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Amway Body Trimmer-202606CT01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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