Effects of exercise training and diet restriction on cardiovascular function in obese population
| ISRCTN | ISRCTN83594346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83594346 |
| Secondary identifying numbers | SAHPL02 |
- Submission date
- 27/04/2017
- Registration date
- 28/04/2017
- Last edited
- 08/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
1268 Middle Guangzhou Avenue
Scientific Research Building Floor 1
Guangzhou Sport University
Guangzhou
510500
China
| Phone | +86 (0)20 3802 5087 |
|---|---|
| 17880383@qq.com |
Scientific
1268 Middle Guangzhou Avenue
Scientific Research Building Floor 1
Guangzhou Sport University
Guangzhou
510500
China
 ORCID ID |
0000-0001-9981-9558 |
|---|---|
| Phone | +86 (0)20 3802 5087 |
| junhaohuang2006@hotmail.com |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of an 8-week combined exercise and diet intervention on endothelial function, autonomic function and arterial stiffness in obese adults |
| Study objectives | Exercise and diet intervention improves endothelial function arterial stiffness and autonomic function in obese adults. |
| Ethics approval(s) | Ethics Committee of Guangzhou Sport University, 17/03/2016, ref: GSU20160012 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 18/03/2016 |
| Completion date | 02/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 22 |
| Key inclusion criteria | 1. Obese adults who had a body mass index (BMI) ≥ 30 kg/m2) 2. Aged 18 and over |
| Key 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 |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 31/07/2016 |
Locations
Countries of recruitment
- China
Study participating centre
516000
China
Sponsor information
University/education
1268 Middle Guangzhou Avenue
Guangzhou
510500
China
| Phone | +86 (0)20 3802 4222 |
|---|---|
| whoomin@hotmail.com | |
"ROR" |
https://ror.org/046r6pk12 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Government organisation / Local government
- Alternative name(s)
- Guangdong Provincial Natural Science Foundation, Natural Science Foundation of Guangdong, Guangdong Natural Science Foundation, Natural Science Fund of Guangdong Province, 廣東省自然科學基金
- Location
- China
No information available
No information available
Results and Publications
| Intention to publish date | 15/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 14/08/2017 | 08/06/2023 | No | No | |
| Other publications | sub study | 05/10/2017 | 08/06/2023 | Yes | No |
| Results article | 14/08/2017 | 08/06/2023 | Yes | No |
Editorial Notes
08/06/2023: Publication references and dataset added.
