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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02075827
Other study ID # UCL0326011
Secondary ID
Status Recruiting
Phase N/A
First received February 24, 2014
Last updated February 27, 2014
Start date February 2014

Study information

Verified date February 2014
Source University College, London
Contact Panos Michael
Phone +44(0)7546842700
Email panos.michael.11@ucl.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Previous studies have shown that subjects who play video games are prone to consume larger quantities of food than subjects who are simply resting. This is believed to be due to the development of a stress response in the video games group, resulting in increased fuel metabolism. However, it was shown that the energy intake of the two groups showed no correlation with the subjects' appetite/hunger, which was identical in both groups.

The investigators propose to explore this issue further by comparing the effects of different types of video games on metabolism, using a randomized controlled trial. In this study, they will compare the stress levels, heart rate, blood pressure, appetite/mood, energy consumption, grip strength, memory and saliva cortisol, leptin and ghrelin levels of subjects playing (a) competitive and (b) problem-solving video games. Measurements will be taken preceding, during and after the 1 hour intervention. Following the intervention, participants will be offered savoury and sweet foods/drinks, which will allow us to assess their appetite preferences and caloric intake.

The investigators first aim is to determine whether there is a significant difference in stress levels, eating habits and energy metabolism in the two groups. Our second aim is to determine whether there is a difference in glucose distribution to the muscles and brain between the two groups.


Description:

The investigators study is designed to test experimentally whether different kinds of video game generate different types of metabolic response. The exposure comprises one-hour of video game playing, with 36 young men randomized to each group (ie 72 in total).

Prior to the exposure, they will collect baseline data on heart rate, blood pressure, anthropometry (weight, height, waist girth), grip strength and cognitive function (memory test), as well as appetite/mood by visual analogue scale (VAS). The investigators will also collect a baseline saliva sample to assess hormones associated with stress (cortisol) or satiety (leptin, ghrelin). The subject will arrive after and overnight fast and will be given a standardised breakfast. After these baseline data are collected, the randomization envelope will be opened and the subject assigned to his group.

Heart rate will be monitored continuously during the study. At 20 and 40 minutes during the intervention, as well as when it ceases at 60 minutes, the investigators will collect further data on blood pressure and appetite/mood by VAS. At 60 minutes, the investigators will repeat measurement of memory and grip strength, and collect a second saliva sample.

For 20 minutes after the end of the intervention, the subject will be allowed to rest, reading magazines, and will be able to select from a range of snack foods (savoury, sweet, fruit), and drinks (sweetened beverages, water). Consumption of calories will be calculated. At the end of this period, final measurements of blood pressure and VAS will be collected, and the subject will depart.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Healthy adult males with BMI <25 kg/m2

Exclusion Criteria:

- smoking

- a significant weight change (>3kg) within the previous three months

- any psychiatric disorder

- uncontrolled hypertension

- coronary heart disease

- heart failure

- central/peripheral arteriopathies

- excessive alcohol consumption (<21 units/week).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Competitive video game
1 hour playing video game
Little Big Planet
1 hour playing video game

Locations

Country Name City State
United Kingdom UCL Institute of Child Health London

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Siervo M, Sabatini S, Fewtrell MS, Wells JC. Acute effects of violent video-game playing on blood pressure and appetite perception in normal-weight young men: a randomized controlled trial. Eur J Clin Nutr. 2013 Dec;67(12):1322-4. doi: 10.1038/ejcn.2013.180. Epub 2013 Oct 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Food intake Subjects will be offered a selection of snacks and drinks over a 20 minute period, and their rates of food intake will be calculated At end of 1-hour video game intervention No
Secondary Blood pressure Blood pressure will be measured in duplicate at 1 minute intervals by digital instrument At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention No
Secondary Heart rate Heart rate will be measured using a polar digital heart rate monitor Continuously, starting during baseline period, from 0 to 60 minutes during intervention, and for 20 minutes post-intervention rest period No
Secondary Salivary leptin Salivary leptin will be analysed using ELISA After 60 minutes from start of intervention No
Secondary Salivary ghrelin Salivary ghrelin will be assessed using ELISA After 60 minutes from start of intervention No
Secondary Salivary cortisol Salivary cortisol will be assessed using ELISA After 60 minutes from start of intervention No
Secondary Visual analogue scale Visual analogue scale will be used to collect subjective data on mood and appetite At 20, 40 and 60 minutes of intervention, and after 20 minutes rest post-intervention No
Secondary Grip strength Grip strength will be assessed by hand-grip dynamometer, using the average of three measurements for each arm After 60 minutes from start of intervention No
Secondary Memory recall Subjects will be shown images for a set time to allow memorization, and then be given another set time to recall as many of these images as possible After 60 minutes from start of intervention No
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