Plain English Summary
Background and study aims
Obesity causes atherosclerosis, where the blood vessels (arteries) become clogged, harden and narrow, which can lead to heart disease. Obesity is also linked to endothelial dysfunction, arterial stiffness and autonomic dysfunction. Endothelial dysfunction, where the endothelium (inner lining) of blood vessels fails to function normally, can be measured using a method called brachial artery flow-mediated dilation (FMD). Pulse wave velocity (PWV), the rate at which the arterial pulse moves down the vessel, is a way to measure arterial stiffness. Autonomic dysfunction is assessed by measuring heart rate variability (HRV), the variation in the time interval between heartbeats. The aim of this study is to investigate the effects of an 8-week combined exercise and diet intervention on endothelial function, autonomic nervous system and arterial stiffness in obese adults.
Who can participate?
Obese adults, aged 18 and over
What does the study involve?
Participants complete an eight-week exercise training and diet intervention. Body measurements and blood samples are taken, and FMD, PWV and HRV are measured before and after the 8-week combined exercise and diet intervention, to find out whether the exercise and diet intervention improves endothelial function, autonomic function and arterial stiffness.
What are the possible benefits and risks of participating?
Exercise training and diet may improve the participants’ health and heart function. The risks of the study are minor, as the physical examinations and procedures are performed by experienced doctors in the appropriate clinical setting and exercise training is individually tailored and supervised by professional trainers. The blood sampling is associated with a small risk of bruise and inflammation of the veins. Vigorous exercise can result in injuries. This risk is minimized by tailoring exercise to the participant’s individual needs, based on the assessment of his or her physical fitness.
Where is the study run from?
Sunstarasia Weight Loss Camp (China)
When is the study starting and how long is it expected to run for?
March 2016 to September 2016
Who is funding the study?
1. National Natural Science Foundation of China
2. Natural Science Foundation of Guangdong Province
3. Foundation of Youth Talents in Higher Education of Guangdong Province of China
4. Pearl River Scholar Program in Guangdong Province of China
Who is the main contact?
1. Miss Dan Wang (public)
17880383@qq.com
2. Prof. Junhao Huang (scientific)
junhaohuang2006@hotmail.com
Trial website
Contact information
Type
Public
Primary contact
Miss Dan Wang
ORCID ID
Contact details
1268 Middle Guangzhou Avenue
Scientific Research Building Floor 1
Guangzhou Sport University
Guangzhou
510500
China
+86 (0)20 3802 5087
17880383@qq.com
Type
Scientific
Additional contact
Prof Junhao Huang
ORCID ID
http://orcid.org/0000-0001-9981-9558
Contact details
1268 Middle Guangzhou Avenue
Scientific Research Building Floor 1
Guangzhou Sport University
Guangzhou
510500
China
+86 (0)20 3802 5087
junhaohuang2006@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SAHPL02
Study information
Scientific title
Effects of an 8-week combined exercise and diet intervention on endothelial function, autonomic function and arterial stiffness in obese adults
Acronym
Study hypothesis
Exercise and diet intervention improves endothelial function arterial stiffness and autonomic function in obese adults.
Ethics approval
Ethics Committee of Guangzhou Sport University, 17/03/2016, ref: GSU20160012
Study design
Obese subjects (BMI ≥ 30 kg/m2) were recruited from the weight loss camp (single-centre) and various parameters were measured before and after 8-week combined exercise and diet intervention.
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Obesity
Intervention
Obese subjects (BMI ≥ 30 kg/m2) were recruited from the weight loss camp after physical examination. The weight loss camp was totally closed with uniformly managed accommodation, diet and training during the 8-week intervention period. The campers lived in the same building, where they could not move in and out freely. Subjects were provided with energy-restricted diets of 1300-2200 kcal/day based on weight. The energy percentages provided by protein, fat and carbohydrate were 20%, 20% and 60%, respectively, while energy distributions at breakfast, lunch and dinner were 30%, 40% and 30%, respectively. All meals were prepared and supervised by registered professional dietitians during the diet intervention. Subjects performed a series of endurance exercise such as bicycling, walking, running, dancing and ball games for 5 hour/day, supplemented with resistance exercise. Training interventions were performed 6 day/week for 8 weeks. The exercise program was designed to result in an energy expenditure of 1500-2500 kcal/day. Qualified trainers supervised the subjects during the training program. Measurements were performed before and after the 8-week combined exercise training and diet intervention.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Endothelial function, assessed by flow-mediated dilation (FMD)
2. Circulating endothelial progenitor cells levels, evaluated by flow cytometry
3. Heart rate variability (HRV), aortic pressure, augmentation pressure, augmentation index, measured using the SphygmoCor device (AtCor Medical, Sydney, Australia)
4. Pulse wave velocity (PWV), measured using both the SphygmoCor device and an oscillometric device (boso ABI-system 100; BOSCH & SOHN, Germany)
Measurements performed before and after the 8-week combined exercise training and diet intervention.
Secondary outcome measures
1. Body composition determined using a body composition analyzer (Inbody 370, Biospace, Seoul, Korea)
2. Resting heart rate (HR) and brachial systolic/diastolic blood pressure (bSBP/bDBP), measured using a sphygmomanometer
3. Aerobic fitness, assessed using the Physical Working Capacity at a heart rate of 150 beats per minute (PWC150) or a heart rate of 170 beats per minute (PWC170) cycle ergometer test (Ergoselect 100, Ergoline, Bitz, Germany)
4. Circulating irisin levels, measured using irisin ELISA kit (Phoenix Pharmaceuticals, CA, USA) following the manufacturer’s instructions
5. Concentrations of vascular endothelial growth factor (VEGF), endothelial nitric oxide synthase (eNOS), adiponectin, tumor necrosis factor-alpha (TNF-α), high-sensitivity C-reactive protein (hsCRP) and superoxide dismutase (SOD) in serum, analyzed using ELISA Kits respectively (Cusabio, Biotech. Co., LTD, Wuhan, China) according to the manufacturer’s instructions
Measurements performed before and after the 8-week combined exercise training and diet intervention.
Overall trial start date
18/03/2016
Overall trial end date
02/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Obese adults who had a body mass index (BMI) ≥ 30 kg/m2)
2. Aged 18 and over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
22
Participant exclusion criteria
1. Unstable angina pectoris
2. Myocardial infarction within the last 12 months
3. Decompensated heart failure
4. Cardiomyopathy
5. Severe valvular heart disease
6. Considerable pulmonary disease
7. Uncontrolled hypertension
8. Kidney failure
9. Orthopaedic and/or neurological limitations to exercise
10. Surgery during the intervention period
11. Drug or alcohol abuse
Recruitment start date
01/04/2016
Recruitment end date
31/07/2016
Locations
Countries of recruitment
China
Trial participating centre
Sunstarasia Weight Loss Camp
Huizhou
516000
China
Sponsor information
Organisation
Guangzhou Sport University
Sponsor details
1268 Middle Guangzhou Avenue
Guangzhou
510500
China
+86 (0)20 3802 4222
whoomin@hotmail.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, Chinese National Science Foundation, NSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
Natural Science Foundation of Guangdong Province
Alternative name(s)
Guangdong Natural Science Foundation, Guangdong Provincial Natural Science Foundation, Natural Science Foundation of Guangdong
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
China
Funder name
Foundation of Youth Talents in Higher Education of Guangdong Province of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pearl River Scholar Program in Guangdong Province of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists plan to publish the results of this study to academic journals this year.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Min Hu (whoomin@hotmail.com).
Intention to publish date
15/07/2017
Participant level data
Available on request
Basic results (scientific)
Publication list