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Explore the Weight Loss Effect of Amway "BODY TRIMMER"

3 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

110

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Principal Investigator
  • Numer telefonu: 18018820470
  • E-mail: shfxec@163.com

Lokalizacje studiów

  • Chiny
      • Shanghai, Chiny
        • Rekrutacyjny
        • Shanghai Fengxian District Central Hospital
        • Kontakt:
          • Principal Investigator
          • Numer telefonu: 18018820470
          • E-mail: shfxec@163.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

30 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Blank control group

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

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

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

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

Amway "BODY TRIMMER"

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Weight
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Blood Pressure
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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).
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline day 0,week4,week8,week12

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

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

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

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Changes in the Abundance of Gut Microbiota in Feces
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amway (China) R&D Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 października 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

1 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

15 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 listopada 2026

Pierwszy wysłany (Rzeczywisty)

9 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Amway Body Trimmer-202606CT01

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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