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

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

42

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
    • Kastamonu
      • Çatalzeytin, Kastamonu, Turkije (Türkiye), 37940
        • Werving
        • Kastamonu University, Çatalzeytin Vocational School
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Concurrent Training Group

Participants assigned to this group will perform supervised concurrent aerobic and resistance training three times per week for eight weeks.
Gedragsmatig: Concurrent Aerobic and Resistance Training

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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Serum PCSK9 Concentration
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Serum LDL Cholesterol Concentration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kastamonu University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

2 november 2026

Primaire voltooiing (Geschat)

30 december 2027

Studie voltooiing (Geschat)

30 mei 2028

Studieregistratiedata

Eerst ingediend

27 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 oktober 2026

Eerst geplaatst (Werkelijk)

2 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KÜBAP2-01/2026-36

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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