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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 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Męski

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Grupa Kontrolna (CON)
Eksperymentalny: Grupa Treningu Aerobowego (ET)
Behawioralne: Supervised Aerobic Exercise

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

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

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

Behawioralne: Supervised Aerobic Exercise

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Waist Circumference
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fasting Blood Glucose
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing Sport University

Śledczy

  • Główny śledczy: Chang Liu, Beijing Sport University, Beijing, Beijing 100084

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

7 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 listopada 2026

Pierwszy wysłany (Rzeczywisty)

13 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB-2026097

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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