Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2017
Date assigned
28/04/2017
Last edited
28/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes