Cistanche Deserticola Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance and Inflammation in Men With Central Obesity

Browse trials for

• Obesity, Abdominal 274
• Insulin Resistance 1,960
• Inflammation 3,439

Keywords

• Aerobic Exercise
• Cistanche deserticola
• Body Composition
• Insulin Resistance
• Inflammation

Obesity, Abdominal

274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.

This study's enrollment of 125 is above the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.

Lead sponsor

Beijing Sport University is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Study arms

• No intervention
  Control Group (CON)
• Experimental
  Cistanche deserticola Group (CD)

  Dietary Supplement: Cistanche deserticola Extract

• Experimental
  Aerobic Exercise Training Group (ET)

  Behavioral: Supervised Aerobic Exercise

• Experimental
  Combined Intervention Group (CDET)

  Behavioral: Supervised Aerobic Exercise · Dietary Supplement: Cistanche deserticola Extract

Interventions

• BehavioralSupervised Aerobic Exercise

  Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 18 weeks, supervised by trained exercise professionals.

• Dietary supplementCistanche deserticola Extract

  Daily oral supplementation with standardized Cistanche deserticola extract for 18 weeks, administered as a capsule or powder.

Primary outcomes

1. Waist Circumference

   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)

   Time frame: Baseline to 18 weeks

2. Height

   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)

   Time frame: Baseline to 18 weeks

3. Body Weight

   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)

   Time frame: Baseline to 18 weeks

4. Body Mass Index (BMI)

   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)

   Time frame: Baseline to 18 weeks

5. Systolic Blood Pressure (SBP)

   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)

   Time frame: Baseline to 18 weeks

6. Diastolic Blood Pressure (DBP)

   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)

   Time frame: Baseline to 18 weeks

7. Body Fat Percentage

   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 (%)

   Time frame: Baseline to 18 weeks

8. Muscle Mass Percentage

   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 (%)

   Time frame: Baseline to 18 weeks

9. Maximal Oxygen Consumption (VO₂max)

   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)

   Time frame: Baseline to 18 weeks

Secondary outcomes

1. Fasting Blood Glucose

   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)

   Time frame: Baseline to 18 weeks

2. Glycated Hemoglobin (HbA1c)

   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 (%)

   Time frame: Baseline to 18 weeks

3. Fasting Insulin

   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)

   Time frame: Baseline to 18 weeks

4. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

   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

   Time frame: Baseline to 18 weeks

5. Homeostatic Model Assessment for Beta Cell Function (HOMA-β)

   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

   Time frame: Baseline to 18 weeks

6. Total Cholesterol (TC)

   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)

   Time frame: Baseline to 18 weeks

7. Triglycerides (TG)

   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)

   Time frame: Baseline to 18 weeks

8. High-Density Lipoprotein (HDL)

   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)

   Time frame: Baseline to 18 weeks

9. Low-Density Lipoprotein (LDL)

   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)

   Time frame: Baseline to 18 weeks

10. Leptin

    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)

    Time frame: Baseline to 18 weeks

11. Ghrelin

    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)

    Time frame: Baseline to 18 weeks

12. C-Reactive Protein (CRP)

    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)

    Time frame: Baseline to 18 weeks

13. Plasminogen Activator Inhibitor-1 (PAI-1)

    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)

    Time frame: Baseline to 18 weeks

14. Gut Microbiota Composition (Phylum/Class/Genus level)

    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)

    Time frame: Baseline to 18 weeks

15. Microbial Differential Abundance (Enterocloster/Gemella)

    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)

    Time frame: Baseline to 18 weeks

16. Short-Chain Fatty Acids (SCFAs) Targeted Metabolomics Detection

    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)

    Time frame: Baseline to 18 weeks

17. Total Daily Energy Intake

    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)

    Time frame: Baseline to 18 weeks

Individual participant data

Plan to share: No