Cistanche Deserticola Extract Combined With Aerobic Exercise Improves Body Composition, Insulin Resistance and Inflammation in Men With Central Obesity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Waist Circumference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Waist Circumference
时间窗: 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)
Height
时间窗: 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)
Body Weight
时间窗: 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)
Body Mass Index (BMI)
时间窗: 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)
Systolic Blood Pressure (SBP)
时间窗: 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)
Diastolic Blood Pressure (DBP)
时间窗: 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)
Body Fat Percentage
时间窗: 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 (%)
Muscle Mass Percentage
时间窗: 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 (%)
Maximal Oxygen Consumption (VO₂max)
时间窗: 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)
次要结局
- 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)
- Total Cholesterol (TC)(Baseline to 18 weeks)
- Triglycerides (TG)(Baseline to 18 weeks)
- High-Density Lipoprotein (HDL)(Baseline to 18 weeks)
- Low-Density Lipoprotein (LDL)(Baseline to 18 weeks)
- Leptin(Baseline to 18 weeks)
- Ghrelin(Baseline to 18 weeks)
- C-Reactive Protein (CRP)(Baseline to 18 weeks)
- Plasminogen Activator Inhibitor-1 (PAI-1)(Baseline to 18 weeks)
- Gut Microbiota Composition (Phylum/Class/Genus level)(Baseline to 18 weeks)
- Microbial Differential Abundance (Enterocloster/Gemella)(Baseline to 18 weeks)
- Short-Chain Fatty Acids (SCFAs) Targeted Metabolomics Detection(Baseline to 18 weeks)
- Total Daily Energy Intake(Baseline to 18 weeks)