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.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Biaoxu Tao
- Numéro de téléphone: 15797892587
- E-mail: taobx020907@gmail.com
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
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Aucune intervention: Groupe témoin (CON)
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Expérimental: Groupe d'Entraînement par Exercice Aérobie (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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Expérimental: 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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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Waist Circumference
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Diastolic Blood Pressure (DBP)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fasting Blood Glucose
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Triglycerides (TG)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Chercheur principal: Chang Liu, Beijing Sport University, Beijing, Beijing 100084
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Poids
- Troubles du métabolisme du glucose
- Hyperinsulinisme
- En surpoids
- Obésité
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Inflammation
- Résistance à l'insuline
- Obésité abdominale
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- IRB-2026097
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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