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Polygonatum Odoratum Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance, Inflammation and Gut Microbiota-SCFA Profiles in Men With Central Obesity

7 novembre 2026 aggiornato da: Beijing Sport University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Gruppo di Controllo (CON)
Sperimentale: Gruppo di Allenamento di Esercizio Aerobico (ET)
Comportamentale: Supervised Aerobic Exercise

Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 90 days, supervised by trained exercise professionals.
Sperimentale: Polygonatum odoratum（PO）
Integratore alimentare: Polygonatum odoratum Extract

Daily oral supplementation with standardized Cistanche deserticola extract for 90 days, administered as a capsule or powder.
Sperimentale: Combined Intervention Group (POET)
Integratore alimentare: Polygonatum odoratum Extract

Daily oral supplementation with standardized Cistanche deserticola extract for 90 days, administered as a capsule or powder.

Comportamentale: Supervised Aerobic Exercise

Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 90 days, supervised by trained exercise professionals.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Waist Circumference
Lasso di tempo: 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
Height
Lasso di tempo: 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
Body Weight
Lasso di tempo: 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
Body Mass Index (BMI)
Lasso di tempo: 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
Systolic Blood Pressure (SBP)
Lasso di tempo: 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
Diastolic Blood Pressure (DBP)
Lasso di tempo: 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
Body Fat Percentage
Lasso di tempo: 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
Muscle Mass Percentage
Lasso di tempo: 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
Maximal Oxygen Consumption (VO₂max)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fasting Blood Glucose
Lasso di tempo: 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
Glycated Hemoglobin (HbA1c)
Lasso di tempo: 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
Fasting Insulin
Lasso di tempo: 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
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Lasso di tempo: 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
Homeostatic Model Assessment for Beta Cell Function (HOMA-β)
Lasso di tempo: 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
Total Cholesterol (TC)
Lasso di tempo: 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
Triglycerides (TG)
Lasso di tempo: 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
High-Density Lipoprotein (HDL)
Lasso di tempo: 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
Low-Density Lipoprotein (LDL)
Lasso di tempo: 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
Leptin
Lasso di tempo: 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
Ghrelin
Lasso di tempo: 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
C-Reactive Protein (CRP)
Lasso di tempo: 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
Plasminogen Activator Inhibitor-1 (PAI-1)
Lasso di tempo: 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
Gut Microbiota Composition (Phylum/Class/Genus level)
Lasso di tempo: 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
Microbial Differential Abundance (Enterocloster/Gemella)
Lasso di tempo: 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
Short-Chain Fatty Acids (SCFAs) Targeted Metabolomics Detection
Lasso di tempo: 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
Total Daily Energy Intake
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Sport University

Investigatori

  • Investigatore principale: Chang Liu, Beijing Sport University, Beijing, Beijing 100084

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

7 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-2026097

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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