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

2 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

42

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Kastamonu
      • Çatalzeytin, Kastamonu, Turquie (Türkiye), 37940
        • Recrutement
        • Kastamonu University, Çatalzeytin Vocational School
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 40 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Concurrent Training Group

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Serum PCSK9 Concentration
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Serum LDL Cholesterol Concentration
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kastamonu University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

2 novembre 2026

Achèvement primaire (Estimé)

30 décembre 2027

Achèvement de l'étude (Estimé)

30 mai 2028

Dates d'inscription aux études

Première soumission

27 octobre 2026

Première soumission répondant aux critères de contrôle qualité

27 octobre 2026

Première publication (Réel)

2 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KÜBAP2-01/2026-36

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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