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Explore the Weight Loss Effect of Amway "BODY TRIMMER"

3. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

110

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Principal Investigator
  • Telefonní číslo: 18018820470
  • E-mail: shfxec@163.com

Studijní místa

  • Čína
      • Shanghai, Čína
        • Nábor
        • Shanghai Fengxian District Central Hospital
        • Kontakt:
          • Principal Investigator
          • Telefonní číslo: 18018820470
          • E-mail: shfxec@163.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

30 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Blank control group

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

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

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

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

Amway "BODY TRIMMER"

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Weight
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Blood Pressure
Časové okno: 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)
Časové okno: 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
Časové okno: 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).
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: baseline day 0,week4,week8,week12

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

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

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

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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in the Abundance of Gut Microbiota in Feces
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Amway (China) R&D Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. října 2026

Primární dokončení (Odhadovaný)

1. února 2027

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

15. října 2026

První předloženo, které splnilo kritéria kontroly kvality

3. listopadu 2026

První zveřejněno (Aktuální)

9. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Amway Body Trimmer-202606CT01

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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