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Completed

NCT Number: NCT07486557

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

This is a randomized controlled trial to see if a combination of aerobic exercise and Cistanche deserticola extract can improve body composition, insulin resistance, and inflammation in men with central obesity. Participants will be randomly assigned to either an intervention group (18 weeks of supervised aerobic exercise plus daily Cistanche extract supplementation) or a control group (usual lifestyle advice). The investigators will measure changes in body fat percentage, muscle mass, blood sugar, insulin levels, and inflammatory markers before and after the 18-week intervention. The goal is to find a safe and effective way to help men with central obesity improve their metabolic health. Possible benefits include better body composition and improved insulin sensitivity. Potential risks are mild muscle soreness or digestive discomfort from the supplement.

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Key information

Conditions

Central Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese males aged 50 to 55 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.

Treatment and study plan

Supervised Aerobic Exercise

Behavioral

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

Cistanche deserticola Extract

Dietary Supplement

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

Primary outcomes

  1. Waist Circumference

    Time frame: Baseline to 18 weeks

    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)

  2. Height

    Time frame: Baseline to 18 weeks

    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)

  3. Body Weight

    Time frame: Baseline to 18 weeks

    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)

  4. Body Mass Index (BMI)

    Time frame: Baseline to 18 weeks

    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)

  5. Systolic Blood Pressure (SBP)

    Time frame: Baseline to 18 weeks

    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)

  6. Diastolic Blood Pressure (DBP)

    Time frame: Baseline to 18 weeks

    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)

  7. Body Fat Percentage

    Time frame: Baseline to 18 weeks

    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 (%)

  8. Muscle Mass Percentage

    Time frame: Baseline to 18 weeks

    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 (%)

  9. Maximal Oxygen Consumption (VO₂max)

    Time frame: Baseline to 18 weeks

    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)

Secondary outcomes

  1. Fasting Blood Glucose

    Time frame: Baseline to 18 weeks

    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)

  2. Glycated Hemoglobin (HbA1c)

    Time frame: Baseline to 18 weeks

    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 (%)

  3. Fasting Insulin

    Time frame: Baseline to 18 weeks

    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)

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

    Time frame: Baseline to 18 weeks

    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

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

    Time frame: Baseline to 18 weeks

    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

  6. Total Cholesterol (TC)

    Time frame: Baseline to 18 weeks

    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)

  7. Triglycerides (TG)

    Time frame: Baseline to 18 weeks

    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)

  8. High-Density Lipoprotein (HDL)

    Time frame: Baseline to 18 weeks

    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)

  9. Low-Density Lipoprotein (LDL)

    Time frame: Baseline to 18 weeks

    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)

  10. Leptin

    Time frame: Baseline to 18 weeks

    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)

  11. Ghrelin

    Time frame: Baseline to 18 weeks

    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)

  12. C-Reactive Protein (CRP)

    Time frame: Baseline to 18 weeks

    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)

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

    Time frame: Baseline to 18 weeks

    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)

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

    Time frame: Baseline to 18 weeks

    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)

  15. Microbial Differential Abundance (Enterocloster/Gemella)

    Time frame: Baseline to 18 weeks

    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)

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

    Time frame: Baseline to 18 weeks

    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)

  17. Total Daily Energy Intake

    Time frame: Baseline to 18 weeks

    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)

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Official study title

Cistanche Deserticola Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance and Inflammation in Men With Central Obesity: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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