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

NCT07486557 | Completed

• 1 other identifier: IRB-2025073
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Obesity; Insulin Resistance; Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (17)

• Fasting Blood Glucose

  Baseline to 18 weeks

• Glycated Hemoglobin (HbA1c)

  Baseline to 18 weeks

• Fasting Insulin

  Baseline to 18 weeks

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Baseline to 18 weeks

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

  Baseline to 18 weeks

Study Arms (4)

Control Group (CON)

NO INTERVENTION

Cistanche deserticola Group (CD)

EXPERIMENTAL

Dietary Supplement: Cistanche deserticola Extract

Aerobic Exercise Training Group (ET)

EXPERIMENTAL

Behavioral: Supervised Aerobic Exercise

Combined Intervention Group (CDET)

EXPERIMENTAL

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

Interventions

Supervised Aerobic Exercise BEHAVIORAL

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

Aerobic Exercise Training Group (ET); Combined Intervention Group (CDET)

Cistanche deserticola Extract DIETARY_SUPPLEMENT

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

Cistanche deserticola Group (CD); Combined Intervention Group (CDET)

Eligibility Criteria

• Age: 50 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Location

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 20, 2026
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)