Polygonatum Odoratum Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance, Inflammation and Gut Microbiota-SCFA Profiles in Men With Central Obesity
Polygonatum Odoratum Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance, Inflammation and Gut Microbiota-SCFA Profiles in Men With Central Obesity: A Randomized Placebo-Controlled Trial
This is a randomized controlled trial to investigate whether a combination of Polygonatum odoratum extract and aerobic exercise can improve body composition, insulin resistance, and inflammation in men with central obesity. Participants will be randomly assigned to either an intervention group (90 days of supervised aerobic exercise combined with daily Polygonatum odoratum extract supplementation) or a control group (usual lifestyle advice). The investigators will measure changes in body fat percentage, muscle mass, blood glucose, insulin levels, inflammatory markers, gut microbiota, and short-chain fatty acids (SCFAs) before and after the 90-day intervention. The goal is to evaluate whether combining Polygonatum odoratum supplementation with aerobic exercise can improve metabolic health in men with central obesity. Possible benefits include improved body composition and insulin sensitivity, as well as favorable changes in gut microbiota and SCFA profiles. Potential risks may include mild muscle soreness associated with exercise and gastrointestinal discomfort related to the supplement.
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Studietype
Studietype
Inschrijving (Geschat)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
Studiecontact
- Naam: Biaoxu Tao
- Telefoonnummer: 15797892587
- E-mail: taobx020907@gmail.com
Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Chinese males aged 40 to 65 years.
- Central obesity, defined as a waist circumference (WC) > 90 cm and a body mass index (BMI) ≥ 25.0 kg/m².
- A daily eating window of ≥ 14 hours.
- Moderate-to-vigorous physical activity (MVPA) ≤ 150 minutes per week.
- Sedentary time ≥ 8 hours per day.
Exclusion Criteria:
- Confirmed diagnosis of cardiovascular disease (CVD) or diabetes mellitus.
- A history of alcohol consumption or tobacco use.
- Diagnosis of conditions (e.g., arthritis) or presence of injuries that impair gait and limit exercise capacity.
- Participation in other clinical trials within 4 weeks prior to enrollment.
- Use of treatments or medications that may affect appetite or metabolism.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
|---|---|
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Geen tussenkomst: Controlegroep (CON)
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Experimenteel: Aerobe Oefentrainingsgroep (ET)
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Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 90 days, supervised by trained exercise professionals. |
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Experimenteel: Polygonatum odoratum(PO)
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Daily oral supplementation with standardized Cistanche deserticola extract for 90 days, administered as a capsule or powder. |
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Experimenteel: Combined Intervention Group (POET)
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Daily oral supplementation with standardized Cistanche deserticola extract for 90 days, administered as a capsule or powder. Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 90 days, supervised by trained exercise professionals. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Waist Circumference
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Lufkin W606PM Metallic Tape;Measurement Method:Measured in accordance with the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK). The measurement site is the midpoint between the iliac crest and the lower costal margin. The subject stands with relaxed abdomen and feet together, and the measurement is repeated at least 3 times to take the average value;Measurement Unit:Centimeter (cm) |
Baseline to 90 days
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Height
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Seca Leicester Stadiometer;Measurement Method:Measured in a standard standing position, barefoot, with the back against the stadiometer and the head kept level;Measurement Unit:Centimeter (cm) |
Baseline to 90 days
|
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Body Weight
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Tanita MC-780 MA Bioelectrical Impedance Analysis Instrument;Measurement Method:Measured after fasting, with light clothing and empty bladder, the measurement is repeated at least 3 times to take the average value;Measurement Unit:Kilogram (kg) |
Baseline to 90 days
|
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Body Mass Index (BMI)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Seca Leicester Stadiometer + Tanita MC-780 MA Bioelectrical Impedance Analysis Instrument;Measurement Method:Calculated by the formula: BMI = Body Weight (kg) / Height² (m²);Measurement Unit:Kilogram per square meter (kg/m²) |
Baseline to 90 days
|
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Systolic Blood Pressure (SBP)
Tijdsspanne: Baseline to 90 days
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Full Name of Measurement Tool:Omron M7 Intelli IT Automatic Blood Pressure Monitor;Measurement Method:Measured in a standard sitting position after the subject rests for 15 minutes, the measurement is repeated 3 times to take the average value;Measurement Unit:Millimeter of mercury (mmHg) |
Baseline to 90 days
|
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Diastolic Blood Pressure (DBP)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Omron M7 Intelli IT Automatic Blood Pressure Monitor;Measurement Method:Measured in a standard sitting position after the subject rests for 15 minutes, the measurement is repeated 3 times to take the average value;Measurement Unit:Millimeter of mercury (mmHg) |
Baseline to 90 days
|
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Body Fat Percentage
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Tanita MC-780 MA Bioelectrical Impedance Analysis Instrument;Measurement Method:Measured after more than 10 hours of fasting and avoiding exercise, alcohol and caffeine for more than 4 hours. The skin electrodes are cleaned before measurement, and the measurement is repeated 3 times to take the average value;Measurement Unit:Percentage (%) |
Baseline to 90 days
|
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Muscle Mass Percentage
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Tanita MC-780 MA Bioelectrical Impedance Analysis Instrument;Measurement Method:Measured after more than 10 hours of fasting and avoiding exercise, alcohol and caffeine for more than 4 hours. The skin electrodes are cleaned before measurement, and the measurement is repeated 3 times to take the average value;Measurement Unit:Percentage (%) |
Baseline to 90 days
|
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Maximal Oxygen Consumption (VO₂max)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Treadmill + Physio-Dyne Instrument Corp. MAX II Metabolic System + Polar H10 Heart Rate Monitor;Measurement Method:The modified Bruce protocol is adopted, the treadmill is subjected to incremental load exercise until exhaustion, and respiratory gas exchange variables and heart rate are recorded in real time;Measurement Unit:Milliliter per kilogram per minute (mL/kg/min) |
Baseline to 90 days
|
Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fasting Blood Glucose
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Bayer AG Contour Plus Blood Glucose Meter;Measurement Method:Venous blood is collected after the subject fasts for 10 hours and detected immediately;Measurement Unit:Millimole per liter (mmol/L) |
Baseline to 90 days
|
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Glycated Hemoglobin (HbA1c)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Roche cobas® b 101 Analyzer;Measurement Method:Venous blood is collected on an empty stomach, and serum is separated for instrument detection;Measurement Unit:Percentage (%) |
Baseline to 90 days
|
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Fasting Insulin
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Mercodia Uppsala Enzyme-Linked Immunosorbent Assay (ELISA) Kit;Measurement Method:Venous blood is collected on an empty stomach, plasma is separated and detected by double replicate ELISA;Measurement Unit:Milliunit per liter (mU/L) |
Baseline to 90 days
|
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Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Bayer AG Contour Plus Blood Glucose Meter + Mercodia Uppsala Enzyme-Linked Immunosorbent Assay (ELISA) Kit;Measurement Method:Calculated by the formula: HOMA-IR = (Fasting Blood Glucose × Fasting Insulin) / 22.5;Measurement Unit:No unit |
Baseline to 90 days
|
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Homeostatic Model Assessment for Beta Cell Function (HOMA-β)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Bayer AG Contour Plus Blood Glucose Meter + Mercodia Uppsala Enzyme-Linked Immunosorbent Assay (ELISA) Kit;Measurement Method:Calculated by the formula: HOMA-β = (20 × Fasting Insulin) / (Fasting Blood Glucose - 3.5);Measurement Unit:No unit |
Baseline to 90 days
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Total Cholesterol (TC)
Tijdsspanne: Baseline to 90 days
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Full Name of Measurement Tool:Roche cobas® c 111 Analyzer;Measurement Method:Venous blood is collected on an empty stomach, and serum is separated for instrument detection;Measurement Unit:Millimole per liter (mmol/L) |
Baseline to 90 days
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Triglycerides (TG)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Roche cobas® c 111 Analyzer;Measurement Method:Venous blood is collected on an empty stomach, and serum is separated for instrument detection;Measurement Unit:Millimole per liter (mmol/L) |
Baseline to 90 days
|
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High-Density Lipoprotein (HDL)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Roche cobas® c 111 Analyzer;Measurement Method:Venous blood is collected on an empty stomach, and serum is separated for instrument detection;Measurement Unit:Millimole per liter (mmol/L) |
Baseline to 90 days
|
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Low-Density Lipoprotein (LDL)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Roche cobas® c 111 Analyzer;Measurement Method:Venous blood is collected on an empty stomach, and serum is separated for instrument detection;Measurement Unit:Millimole per liter (mmol/L) |
Baseline to 90 days
|
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Leptin
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:ImmunoDiagnostics Limited / Thermo Fisher Scientific Enzyme-Linked Immunosorbent Assay (ELISA) Kit;Measurement Method:Venous blood is collected on an empty stomach, plasma is separated and detected by double replicate ELISA;Measurement Unit:Nanogram per milliliter (ng/ml) |
Baseline to 90 days
|
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Ghrelin
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Bio-Rad Hercules California Luminex Assay Kit;Measurement Method:Venous blood is collected on an empty stomach, plasma is separated and detected by magnetic bead-based Luminex assay;Measurement Unit:Picogram per milliliter (pg/ml) |
Baseline to 90 days
|
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C-Reactive Protein (CRP)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:ImmunoDiagnostics Limited / Thermo Fisher Scientific Enzyme-Linked Immunosorbent Assay (ELISA) Kit;Measurement Method:Venous blood is collected on an empty stomach, plasma is separated and detected by double replicate ELISA;Measurement Unit:Microgram per milliliter (ug/ml) |
Baseline to 90 days
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Plasminogen Activator Inhibitor-1 (PAI-1)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Bio-Rad Hercules California Luminex Assay Kit;Measurement Method:Venous blood is collected on an empty stomach, plasma is separated and detected by magnetic bead-based Luminex assay;Measurement Unit:Picogram per milliliter (pg/ml) |
Baseline to 90 days
|
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Gut Microbiota Composition (Phylum/Class/Genus level)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Omega BIO-TEK Norcross E.Z.N.A.® Stool DNA Kit + BGI Genomics 16S/18S/ITS Amplicon Metagenomic Sequencing Platform;Measurement Method:Fecal samples are provided by subjects on an empty stomach, transported on ice within 2 hours or frozen at -80℃; microbial DNA is extracted for 16S rRNA amplicon sequencing, and taxonomic composition is analyzed by software such as DADA2 and phyloseq;Measurement Unit:Relative abundance (%) / No unit (sequencing read count) |
Baseline to 90 days
|
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Microbial Differential Abundance (Enterocloster/Gemella)
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:BGI Genomics 16S/18S/ITS Amplicon Metagenomic Sequencing Platform + R Language (emmeans/vegan package);Measurement Method:Analyzed by Δabundance (post-intervention - pre-intervention), combined with Analysis of Covariance (ANCOVA) and Permutational Multivariate Analysis of Variance (PERMANOVA) statistical tests;Measurement Unit:No unit (standardized abundance value) |
Baseline to 90 days
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Short-Chain Fatty Acids (SCFAs) Targeted Metabolomics Detection
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Thermo ScientificTM TSQ Altis Mass Spectrometer + Thermo Scientific Vanquish TM Flex Ultra-High Performance Liquid Chromatograph + Waters ACQUITY UPLC BEH C18 Chromatographic Column;Measurement Method:Prepare SCFA standards and isotope internal standards, extract biological sample metabolites. UHPLC-MS/MS detection with gradient elution (40°C, 2μL injection, 0.3mL/min flow rate), ESI negative ion MRM mode; validate via linearity, precision, accuracy, stability and QC. Quantify with standard/internal standard ratio standard curve; conduct PCA, clustering, KEGG annotation and differential metabolite screening;Measurement Unit:nanogram per milliliter (ng/mL) / microgram per milliliter (ug/mL) |
Baseline to 90 days
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Total Daily Energy Intake
Tijdsspanne: Baseline to 90 days
|
Full Name of Measurement Tool:Dietary Record(MyFitnessPal APP); trained dietitians calculate total daily energy intake using nutrient databases; compliance is assessed during study visits;Measurement Unit:Kilocalorie per day (kcal/d) |
Baseline to 90 days
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Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
Onderzoekers
- Hoofdonderzoeker: Chang Liu, Beijing Sport University, Beijing, Beijing 100084
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Studie start
Primaire voltooiing (Geschat)
Primaire voltooiing
Studie voltooiing (Geschat)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Voedingsstoornissen
- Metabole ziekten
- Overvoeding
- Lichaamsgewicht
- Glucosemetabolismestoornissen
- Hyperinsulinisme
- Overgewicht
- Obesitas
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Ontsteking
- Insuline-resistentie
- Obesitas, buik
Andere studie-ID-nummers
Andere studie-ID-nummers
- IRB-2026097
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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