An interventional study of Concurrent Aerobic and Resistance Training in Overweight, Lipid Metabolism and Cholesterol Metabolism, sponsored by Kastamonu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Kastamonu University · Not applicable, Interventional, and Basic science
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.
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.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 42 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Kastamonu University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group will perform supervised concurrent aerobic and resistance training three times per week for eight weeks.
Behavioral: Concurrent Aerobic and Resistance Training
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.
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.
Change in Serum PCSK9 Concentration
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.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum LDL Cholesterol Concentration
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.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum HDL Cholesterol Concentration
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.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum Total Cholesterol Concentration
Serum total cholesterol concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum Triglyceride Concentration
Serum triglyceride concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fasting Serum Glucose Concentration
Fasting serum glucose concentration will be measured using an enzymatic colorimetric method. Changes over time will be compared between groups.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Weight
Body weight will be measured in kilograms (kg) using a digital scale (Tanita RD-545).
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist Circumference
Waist circumference will be measured in centimeters (cm) at the midpoint between the lowest rib and iliac crest.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Hip Circumference
Hip circumference will be measured in centimeters (cm) at the widest part of the hips.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Hip Ratio
Waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. The ratio is dimensionless.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Height Ratio
Waist-to-height ratio will be calculated by dividing waist circumference by height, expressed in the same units. The ratio is dimensionless.
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Fat Percentage
Body fat percentage (%) will be assessed using bioelectrical impedance analysis (Tanita RD-545).
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fat Mass
Total body fat mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fat-Free Mass
Fat-free mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Muscle Mass
Muscle mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Time frame: At baseline and 4 and 8 weeks after baseline
Plan to share: No — 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.
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