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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04294238
Other study ID # SYSEC-KY-KS-2019-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2018
Est. completion date February 20, 2020

Study information

Verified date March 2020
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date February 20, 2020
Est. primary completion date January 20, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage change of HDL cholesterol efflux capacity The primary outcome was the mearsurement of HDL function for removing excess cholesterol from peripheral cells 12 week
Primary Proteome alteration of HDL subclass HDL proteome was analyzed by mass spectrometry using label-free protein quantification. 12 week
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