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Effects of Concurrent Training on Serum PCSK9 Levels in Adults With Overweight

2026年11月2日 更新者:Yasin Ak、Kastamonu University

Effects of Concurrent Training on Serum PCSK9 Levels in Adults With Overweight: A Randomized Controlled Trial

Being overweight can increase the risk of heart disease. PCSK9 is a protein that helps regulate cholesterol levels in the blood. Exercise may affect PCSK9 levels, but previous studies have reported conflicting results.

The purpose of this study is to determine whether a program combining aerobic exercise and resistance training changes blood PCSK9 levels in adults with overweight. The researchers will also examine changes in blood cholesterol levels and body composition.

A total of 42 adults aged 18-40 years with overweight will be randomly assigned to one of two groups. One group will participate in a supervised exercise program three days per week for eight weeks. Each session will last approximately 60 minutes and include aerobic exercise, resistance training, warm-up, and cool-down periods. The other group will continue their usual daily activities without participating in a structured exercise program provided by the study.

Blood samples and body measurements will be collected before the program, after four weeks, and after eight weeks. Participants will also record their usual food intake and physical activity during the study.

The researchers expect that the combined exercise program may reduce blood PCSK9 levels compared with maintaining usual daily activities. The findings may help improve understanding of how exercise affects cholesterol regulation in adults with overweight.

研究概览

详细说明

Background and Rationale

Overweight is associated with an increased risk of cardiovascular disease, partly through adverse changes in blood lipid levels. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a protein involved in cholesterol regulation. It binds to low-density lipoprotein receptors (LDLR) and promotes their degradation, thereby reducing the removal of low-density lipoprotein cholesterol (LDL-C) from the bloodstream.

Regular exercise is an important lifestyle strategy for improving cardiovascular health and lipid metabolism. Previous research suggests that exercise may influence circulating PCSK9 levels, potentially contributing to changes in cholesterol regulation. However, studies investigating the effects of physical activity and exercise on PCSK9 have reported conflicting findings, with some showing reductions and others reporting increases. Therefore, the effects of structured exercise training on circulating PCSK9 levels remain unclear.

Study Objectives

The primary objective of this study is to investigate the effects of an eight-week concurrent aerobic and resistance training program on serum PCSK9 levels in adults with overweight, compared with a control group maintaining their usual daily activities.

The study will also examine changes in blood lipid levels, glucose concentrations, anthropometric measurements, and body composition. Additionally, the relationship between serum PCSK9 levels and body composition will be investigated.

Study Design and Procedures

This study is designed as a single-center, two-arm, parallel-group randomized controlled trial. Participants will be randomly allocated to either a supervised concurrent training group or a non-exercising control group using block randomization with a 1:1 allocation ratio.

The exercise program will combine aerobic and resistance training under professional supervision. Participants in the control group will be asked to maintain their usual daily activities without receiving a structured exercise intervention.

Biochemical, anthropometric, and body composition assessments will be performed at baseline, 4 and 8 weeks after baseline. Blood samples will be collected after an overnight fast to assess serum PCSK9 and metabolic markers.

To help account for potential changes in lifestyle behaviors, dietary intake and habitual physical activity will be monitored throughout the study using three-day dietary records and three-day physical activity records at the specified assessment periods.

Expected Contribution

This study is expected to provide evidence regarding the effects of concurrent aerobic and resistance training on circulating PCSK9 levels in adults with overweight. The findings may contribute to a better understanding of the relationship between exercise, PCSK9, and cholesterol metabolism and may help inform future research on exercise-based approaches to cardiovascular risk management.

研究类型

介入性

注册 (估计的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Kastamonu
      • Çatalzeytin、Kastamonu、土耳其(türkiye)、37940
        • 招聘中
        • Kastamonu University, Çatalzeytin Vocational School
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18-40 years.
  • Body mass index (BMI) between 25.0 and 29.9 kg/m².
  • No participation in a regular exercise program during the previous two months (3-5 days per week, totaling 150 minutes per week).

Exclusion Criteria:

  • Diagnosed coronary artery disease, heart failure, hypertension, diabetes mellitus, or other chronic cardiovascular or metabolic diseases.
  • Acute or chronic inflammatory disease or active infection.
  • History of malignancy or active cancer.
  • Neurological, orthopedic, or musculoskeletal conditions that prevent participation in physical exercise.
  • Current use of antihypertensive, lipid-lowering, antidiabetic, systemic glucocorticoid, or other medications that may affect PCSK9 levels.
  • Current smoking or use of other tobacco products.
  • Pregnancy or breastfeeding.
  • Loss of 5% or more of body weight during the previous three months or participation in a weight-loss diet.
  • Bariatric surgery or use of pharmacological weight-management treatment during the previous three months.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Concurrent Training Group

Participants assigned to this group will perform supervised concurrent aerobic and resistance training three times per week for eight weeks.

Participants in the intervention group will complete an eight-week supervised concurrent aerobic and resistance training program, consisting of three sessions per week. Each 60-minute session will include a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance exercise, and a 5-minute cool-down.

Aerobic exercise will be performed on a treadmill or cycle ergometer at 40-60% of heart rate reserve.

Resistance training will include eight exercises targeting major muscle groups: chest press, lat pull-down, hamstring curl, quadriceps extension, shoulder press, biceps curl, triceps extension, and abdominal crunch. Participants will perform two sets of 8-16 repetitions at 50-80% of their 10-repetition maximum, with approximately one minute of rest between sets.

All sessions will be conducted under professional supervision. Heart rate and perceived exertion will be monitored during exercise using a heart rate monitor and the Borg Rating of Perceived Exertion Scale.

无干预:Control Group

Participants assigned to the control group will not receive a structured exercise intervention. They will be instructed to maintain their usual physical activity, dietary habits, and daily routines throughout the eight-week study period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Serum PCSK9 Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Serum PCSK9 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Changes over time will be compared between the concurrent training and control groups.

At baseline and 4 and 8 weeks after baseline

次要结果测量

结果测量
措施说明
大体时间
Change in Serum LDL Cholesterol Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Serum low-density lipoprotein cholesterol (LDL-C) concentration will be assessed from fasting blood samples. Changes over time will be compared between the concurrent training and control groups.

At baseline and 4 and 8 weeks after baseline
Change in Serum HDL Cholesterol Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Serum high-density lipoprotein cholesterol (HDL-C) concentration will be assessed from fasting blood samples. Changes over time will be compared between the concurrent training and control groups.

At baseline and 4 and 8 weeks after baseline
Change in Serum Total Cholesterol Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Serum total cholesterol concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.

At baseline and 4 and 8 weeks after baseline
Change in Serum Triglyceride Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Serum triglyceride concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.

At baseline and 4 and 8 weeks after baseline
Change in Fasting Serum Glucose Concentration
大体时间:At baseline and 4 and 8 weeks after baseline

Fasting serum glucose concentration will be measured using an enzymatic colorimetric method. Changes over time will be compared between groups.

At baseline and 4 and 8 weeks after baseline
Change in Body Weight
大体时间:At baseline and 4 and 8 weeks after baseline

Body weight will be measured in kilograms (kg) using a digital scale (Tanita RD-545).

At baseline and 4 and 8 weeks after baseline
Change in Body Mass Index
大体时间:At baseline and 4 and 8 weeks after baseline

Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).

At baseline and 4 and 8 weeks after baseline
Change in Waist Circumference
大体时间:At baseline and 4 and 8 weeks after baseline

Waist circumference will be measured in centimeters (cm) at the midpoint between the lowest rib and iliac crest.

At baseline and 4 and 8 weeks after baseline
Change in Hip Circumference
大体时间:At baseline and 4 and 8 weeks after baseline

Hip circumference will be measured in centimeters (cm) at the widest part of the hips.

At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Hip Ratio
大体时间:At baseline and 4 and 8 weeks after baseline

Waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. The ratio is dimensionless.

At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Height Ratio
大体时间:At baseline and 4 and 8 weeks after baseline

Waist-to-height ratio will be calculated by dividing waist circumference by height, expressed in the same units. The ratio is dimensionless.

At baseline and 4 and 8 weeks after baseline
Change in Body Fat Percentage
大体时间:At baseline and 4 and 8 weeks after baseline

Body fat percentage (%) will be assessed using bioelectrical impedance analysis (Tanita RD-545).

At baseline and 4 and 8 weeks after baseline
Change in Fat Mass
大体时间:At baseline and 4 and 8 weeks after baseline

Total body fat mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).

At baseline and 4 and 8 weeks after baseline
Change in Fat-Free Mass
大体时间:At baseline and 4 and 8 weeks after baseline

Fat-free mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).

At baseline and 4 and 8 weeks after baseline
Change in Muscle Mass
大体时间:At baseline and 4 and 8 weeks after baseline

Muscle mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).

At baseline and 4 and 8 weeks after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月2日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2028年5月30日

研究注册日期

首次提交

2026年10月27日

首先提交符合 QC 标准的

2026年10月27日

首次发布 (实际的)

2026年11月2日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared with external researchers. The informed consent form provides for the use and processing of participant data for the approved study but does not explicitly address secondary data sharing with external researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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