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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. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

200

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Kontrolní skupina (CON)
Experimentální: Skupina aerobního cvičení (ET)

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

Experimentální: Polygonatum odoratum(PO)

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

Experimentální: Combined Intervention Group (POET)

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Waist Circumference
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fasting Blood Glucose
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Chang Liu, Beijing Sport University, Beijing, Beijing 100084

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. ledna 2027

Dokončení studie (Odhadovaný)

1. března 2027

Termíny zápisu do studia

První předloženo

7. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

7. listopadu 2026

První zveřejněno (Aktuální)

13. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • IRB-2026097

Plán pro data jednotlivých účastníků (IPD)

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Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .