Explore the Weight Loss Effect of Amway "BODY TRIMMER"
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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Principal Investigator
- Telefonnummer: 18018820470
- E-Mail: shfxec@163.com
Studienorte
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Shanghai, China
- Rekrutierung
- Shanghai Fengxian District Central Hospital
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Kontakt:
- Principal Investigator
- Telefonnummer: 18018820470
- E-Mail: shfxec@163.com
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-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Kein Eingriff: Blank control group
Subjects maintain their usual diet and daily lifestyle, and no investigational product is administered during the study period. |
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Experimental: Experimental group 1 (Low Dose Arm)
Amway "BODY TRIMMER", oral powder, 1 sachet administered once daily. |
Amway "BODY TRIMMER" |
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Experimental: Experimental group 2 (High Dose Arm)
Amway "BODY TRIMMER", oral powder, 2 sachets administered once daily. |
Amway "BODY TRIMMER" |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Weight
Zeitfenster: baseline day 0,week4,week8,week12
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Changes from weight in the high-dose, low-dose and blank control groups. |
baseline day 0,week4,week8,week12
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Blood Pressure
Zeitfenster: 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
|
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BMI (Body Mass Index)
Zeitfenster: 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
|
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Improvement of Fat and Muscle Portions and Body Fat Percentage measured by Inbody S10 or S770 from baseline
Zeitfenster: 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
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Changes from baseline in abdominal fat (Android fat % and Gynoid fat %) measured by dual-energy X-ray absorptiometry (DXA).
Zeitfenster: 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
|
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Blood Lipids
Zeitfenster: 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
Zeitfenster: 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
|
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Serum Insulin
Zeitfenster: baseline day 0,week12
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Between-group comparisons among the high-dose group, low-dose group, and blank control group at 12-week follow-up. |
baseline day 0,week12
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C-reactive protein (CRP)
Zeitfenster: 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
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1L-6
Zeitfenster: 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
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Glycated Hemoglobin (HbA1c)
Zeitfenster: 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
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Appetite Visual Analogue Scale (VAS)
Zeitfenster: baseline day 0,week4,week8,week12
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Visual Analogue Scale (VAS) The VAS was used to assess satiety, with scores ranging from 0 to 30 points.
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baseline day 0,week4,week8,week12
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Dietary Pattern and Fat Intake Assessment (total score: 10-40 points)
Zeitfenster: baseline day 0,week4,week8,week12
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baseline day 0,week4,week8,week12
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Physical Activity Assessment (total score: 3-12 points)
Zeitfenster: baseline day 0,week4,week8,week12
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baseline day 0,week4,week8,week12
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Alanine Aminotransferase (ALT)
Zeitfenster: 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
|
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Aspartate Aminotransferase (AST)
Zeitfenster: 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
|
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Alkaline Phosphatase (ALP)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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Total Protein (TP)
Zeitfenster: 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
|
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Uric Acid
Zeitfenster: 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
|
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Serum Creatinine (Scr)
Zeitfenster: 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
|
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Serum Urea
Zeitfenster: 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
|
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Waist Circumference
Zeitfenster: baseline day 0,week4,week8,week12
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Waist circumference measured by soft tape measure, unit: cm. |
baseline day 0,week4,week8,week12
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Hip Circumference
Zeitfenster: baseline day 0,week4,week8,week12
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Hip circumference measured by soft tape measure, unit: cm. |
baseline day 0,week4,week8,week12
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Thigh Circumference
Zeitfenster: baseline day 0,week4,week8,week12
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Thigh circumference measured by soft tape measure, unit: cm. |
baseline day 0,week4,week8,week12
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Upper-arm Circumference
Zeitfenster: baseline day 0,week4,week8,week12
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Upper-arm circumference measured by soft tape measure, unit: cm. |
baseline day 0,week4,week8,week12
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Waist-to-Hip Ratio
Zeitfenster: baseline day 0,week4,week8,week12
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Ratio of waist circumference to hip circumference, dimensionless. |
baseline day 0,week4,week8,week12
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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in the Abundance of Gut Microbiota in Feces
Zeitfenster: baseline day 0,week12
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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
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Changes in Metabolic Byproducts in Feces
Zeitfenster: baseline day 0,week12
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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
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- Amway Body Trimmer-202606CT01
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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