The Function and Proteome Alteration of HDL Subclass After Aerobic Exercise

March 2, 2020 updated by: Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Effects of Moderate Aerobic Exercise on the Proteome and Function Alteration of HDL Sub-Fractions in Male Youth With Abdominal Obesity

Obesity is one of the most important risk factors for cardiovascular disease (CVD). HDL protein composition can be altered without a change in cholesterol content. Alteration of the HDL proteome can result in dysfunctional HDL particles with reduced ability to protect against CVD. The aim of this study was to evaluate the influence of moderate aerobic exercise on HDL protein composition and its related function. This was a self-control study including 6 inactive male youths with abdominal obesity. HDL functions and its associations with proteome alteration would be analysized.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of present study is to test the effects of 12-week moderate aerobic exercise on the proteome and function alteration of HDL sub-fractions in male youth with abdominal obesity.

Study participants: youth males with abdominal obesity between the ages of 18 and 30 years were eligible for participation. Exclusion criteria were cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months. This study was approved by the Medical Ethics Committee at the Sun Yat-sen Memorial Hospital, complies with the Declaration of Helsinki principles and written informed consent would be obtained from all participants.

Data collection: anthropometric measurements, physical examination and blood samples were collected at 0 and 12 weeks. Cardiorespiratory measurements of each participant was measured using a bicycle-based graded exercise test at baseline.

Intervention: the exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. All participants were instructed to maintain their usual dietary intakes. Completing a minimum of 80 percentage training sessions was satisfactory.

HDL isolation: HDL particles were fractionated into small, medium and large (S/M/L)-HDL subfractions by an ÄKTA fast protein liquid chromatography (FPLC) system.

Proteomics Experiments: equal volumes of L/M/S-HDL subclass were applied to the CSH resin, trypsinized, and then recognized via LC-MS. HDL proteins in HDL subclass were detected by MS-based label-free quantitation

HDL functions: cholesterol efflux capacity, anti-inflammation and anti-oxidative capacity, endothelial protective function

Analysis: data are expressed as mean and SD for continuous variables, or percentage for category variables. Difference of variables between baseline and after exercise were compared using analysis of Paired t-test or Mann Whitney U test. P<0.05 was considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Inactive youth males with abdominal obesity: BMI>28 (weight in kilograms divided by height in meters squared) and weight stable for 6 months, waist to height ratio was ≥0.5 and/or waist circumference was ≥102 centimetres between the ages of 18 and 30 years.

Exclusion Criteria:

  • Participants with cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Post-exercise
The aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week.
Behavioral: Aerobic exercise
The aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage change of HDL cholesterol efflux capacity
Time Frame: 12 week
The primary outcome was the mearsurement of HDL function for removing excess cholesterol from peripheral cells
12 week
Proteome alteration of HDL subclass
Time Frame: 12 week
HDL proteome was analyzed by mass spectrometry using label-free protein quantification.
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSEC-KY-KS-2019-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Due to restrictions that protect participant privacy, data are available upon request. The data ( study protocol) will be available upon request to all interested researchers.

IPD Sharing Time Frame

The data will become available at 01/01/2021 and for 1 year.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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