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

2026년 11월 2일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Kastamonu
      • Çatalzeytin, Kastamonu, 터키 (Türkiye), 37940
        • 모병
        • Kastamonu University, Çatalzeytin Vocational School
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Serum PCSK9 Concentration
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Serum LDL Cholesterol Concentration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 2일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2028년 5월 30일

연구 등록 날짜

최초 제출

2026년 10월 27일

QC 기준을 충족하는 최초 제출

2026년 10월 27일

처음 게시됨 (실제)

2026년 11월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • KÜBAP2-01/2026-36

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .