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

2 ноября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

42

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Yasin Ak, PhD
  • Номер телефона: +90 538 443 96 25
  • Электронная почта: fztyaso5@gmail.com

Места учебы

  • Турция (Туркие)
    • Kastamonu
      • Çatalzeytin, Kastamonu, Турция (Туркие), 37940
        • Рекрутинг
        • Kastamonu University, Çatalzeytin Vocational School
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 40 лет (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Фундаментальная наука
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Concurrent Training Group

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Serum PCSK9 Concentration
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Serum LDL Cholesterol Concentration
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Kastamonu University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

2 ноября 2026 г.

Первичное завершение (Оцененный)

30 декабря 2027 г.

Завершение исследования (Оцененный)

30 мая 2028 г.

Даты регистрации исследования

Первый отправленный

27 октября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

27 октября 2026 г.

Первый опубликованный (Действительный)

2 ноября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • KÜBAP2-01/2026-36

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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