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ReclutandoNCT07924956Registro de ClinicalTrials.gov

Explore the Weight Loss Effect of Amway "BODY TRIMMER"

Abdominal Obesity

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
30 años - 65 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
110 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Sin asignación al azar
Enmascaramiento
Sin enmascaramiento
Blank control group

Subjects maintain their usual diet and daily lifestyle, and no investigational product is administered during the study period.

Experimental group 1 (Low Dose Arm)

Amway "BODY TRIMMER", oral powder, 1 sachet administered once daily.

Other: Body trimmer intervention dose 1

Experimental group 2 (High Dose Arm)

Amway "BODY TRIMMER", oral powder, 2 sachets administered once daily.

Other: Body trimmer intervention dose 2

Body trimmer intervention dose 1 OTHER

Amway "BODY TRIMMER"

Body trimmer intervention dose 2 OTHER

Amway "BODY TRIMMER"

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Weight

Plazo: baseline day 0,week4,week8,week12

Changes from weight in the high-dose, low-dose and blank control groups.

Medidas secundarias

Blood Pressure

Plazo: 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.

BMI (Body Mass Index)

Plazo: 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.

Improvement of Fat and Muscle Portions and Body Fat Percentage measured by Inbody S10 or S770 from baseline

Plazo: 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.

Changes from baseline in abdominal fat (Android fat % and Gynoid fat %) measured by dual-energy X-ray absorptiometry (DXA).

Plazo: 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.

Blood Lipids

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Blood Glucose

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Serum Insulin

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

C-reactive protein (CRP)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

1L-6

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Glycated Hemoglobin (HbA1c)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Appetite Visual Analogue Scale (VAS)

Plazo: 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
Dietary Pattern and Fat Intake Assessment (total score: 10-40 points)

Plazo: 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
Physical Activity Assessment (total score: 3-12 points)

Plazo: 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
Alanine Aminotransferase (ALT)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Aspartate Aminotransferase (AST)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Alkaline Phosphatase (ALP)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Gamma-Glutamyl Transferase (GGT)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Total Bilirubin (TBIL)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Direct Bilirubin (DBIL)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Total Protein (TP)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Uric Acid

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Serum Creatinine (Scr)

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Serum Urea

Plazo: baseline day 0,week12

Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up.

Waist Circumference

Plazo: baseline day 0,week4,week8,week12

Waist circumference measured by soft tape measure, unit: cm.

Hip Circumference

Plazo: baseline day 0,week4,week8,week12

Hip circumference measured by soft tape measure, unit: cm.

Thigh Circumference

Plazo: baseline day 0,week4,week8,week12

Thigh circumference measured by soft tape measure, unit: cm.

Upper-arm Circumference

Plazo: baseline day 0,week4,week8,week12

Upper-arm circumference measured by soft tape measure, unit: cm.

Waist-to-Hip Ratio

Plazo: baseline day 0,week4,week8,week12

Ratio of waist circumference to hip circumference, dimensionless.

Otras medidas

Changes in the Abundance of Gut Microbiota in Feces

Plazo: 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

Changes in Metabolic Byproducts in Feces

Plazo: 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).

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Shanghai Fengxian District Central HospitalShanghai, ChinaReclutando

Equipo y fechas

Patrocinador principal
Amway (China) R&D Center
Inicio del estudio
15 oct 2026 Real
Finalización primaria
2027-02 Estimado
Finalización del estudio
2027-02 Estimado
Primera publicación
9 nov 2026 Real
Última actualización
9 nov 2026 Real

Contactos oficiales del estudio

Principal InvestigatorCONTACTshfxec@163.com18018820470
Título oficial del estudio

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

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026