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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Insulin Resistance; Central Obesity
• Intervention / Treatment: Dietary supplement: Cistanche deserticola Extract; Behavioral: Supervised Aerobic Exercise

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100084
      • Beijing Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (CON)
Experimental: Cistanche deserticola Group (CD)	Dietary supplement: Cistanche deserticola Extract; Daily oral supplementation with standardized Cistanche deserticola extract for 18 weeks, administered as a capsule or powder.
Experimental: Aerobic Exercise Training Group (ET)	Behavioral: Supervised Aerobic Exercise; Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 18 weeks, supervised by trained exercise professionals.
Experimental: Combined Intervention Group (CDET)	Dietary supplement: Cistanche deserticola Extract; Daily oral supplementation with standardized Cistanche deserticola extract for 18 weeks, administered as a capsule or powder.; Behavioral: Supervised Aerobic Exercise; Moderate-intensity aerobic exercise 3 times per week, 40 minutes per session, for 18 weeks, supervised by trained exercise professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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 (%)	Baseline to 18 weeks
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 (%)	Baseline to 18 weeks
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)	Baseline to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline to 18 weeks
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 (%)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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	Baseline to 18 weeks
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	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks
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)	Baseline to 18 weeks

Collaborators and Investigators

• Sponsor: Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Insulin Resistance; Body Composition; Aerobic Exercise; Cistanche deserticola
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Inflammation; Insulin Resistance; Obesity, Abdominal
• Other Study ID Numbers: IRB-2025073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No