Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/03/2019
Date assigned
05/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When people eat high-fat meals, levels of a component of fat called triglycerides increase in their blood. High blood triglyceride levels are linked to an increased risk of cardiovascular (heart and blood circulation) disease. Playing football is a form of exercise that has been shown to have several health benefits, however it is not known what is the most appropriate number of weekly sessions. This study aims to compare the effect of football training on a single day or over three consecutive days on triglyceride, other fat components, insulin and glucose levels in the blood.

Who can participate?
Men aged 20-40 years with no current medical conditions or injuries and in general good health, who are capable of performing intense exercise

What does the study involve?
Participants will be randomly allocated to perform either one football training session (on day 7) or three consecutive days (on days 5, 6 and 7) of football training. On the first visit (day 1), all participants will visit the clinic without having eaten for at least 10 hours. A sample of blood will be taken. Then the participants will consume a high-fat milkshake containing ice cream and cream, with the amount of milkshake adjusted for their body weight. Blood samples will be taken 45 minutes and 2, 4 and 6 hours after the meal. The participants will then do 1 hour of football training on their allocated days. On day 8, they will again visit the clinic without having eaten for at least 10 hours. A sample of blood will be taken. Then the participants will consume a high-fat milkshake containing ice cream and cream, with the amount of milkshake adjusted for their body weight. Blood samples will be taken 45 minutes and 2, 4 and 6 hours after the meal.

What are the possible benefits and risks of participating?
Playing football has been shown to have many health benefits (physical, physiological, psychological and social). There may be a small risk of injury performing the training sessions.

Where is the study run from?
This study will work across two centres, Aspetar Sports Medicine and Orthopaedic Hospital and the University of Copenhagen. The actual study will be performed and managed from Aspetar Sports Medicine Hospital (Qatar).

When is the study starting and how long is it expected to run for?
August 2014 to August 2018

Who is funding the study?
Aspetar Sports Medicine Hospital (Qatar)

Who is the main contact?
Darren Paul (Exercise Physiologist, Aspetar Sports Medicine Hospital)
darren.paul@aspetar.com

Trial website

Contact information

Type

Public

Primary contact

Mr Darren Paul

ORCID ID

http://orcid.org/0000-0002-4583-1006

Contact details

Aspetar Orthopaedic and Sports Medicine Hospital
Doha
29222
Qatar
0097470097869
darren.paul@aspetar.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

F2015000112

Study information

Scientific title

The effects of a single versus three consecutive sessions of football training on postprandial lipaemia

Acronym

FTPL

Study hypothesis

Performing three consecutive sessions of football training will attenuate postprandial lipaemia more than a single football session

Ethics approval

Approved 23/11/2015 and renewed 20/11/2016, Anti-Doping Lab Qatar Institutional Review Board (PO Box 27775, Doha, Qatar; 974 4413 2900; info.adl@adlqatar.com), ref: E20140000014

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Hyperlipidemia

Intervention

15 males performed either one (1FOOT; n= 7) or three (3FOOT; n= 8) 60-min football training sessions. On day 1, participants arrived at the laboratory at approximately 08:00 hrs after an overnight fast (>10 h). Following a 15-min seated rest period and debrief, a cannula was inserted into an antecubital vein and a baseline venous sample was collected by a qualified phlebotomist. Participants were then given a high-fat meal, in the form of a Belgian chocolate ice cream (Häagen-Dazs) and whipping cream (Elmlea) shake, with the meal being well tolerated by all participants. On day 1, a blood sample was collected at fasted (0 min) and 0.75, 2, 4, 6 h after the high-fat meal. Participants were then randomly allocated to either 1 day (1FOOT; day 7) or 3 days (3FOOT; days 5, 6, 7) of football training. On day 8, they repeated the high-fat meal and blood sampling for the 6 hours following the meal. To control for confounding variables, participants were instructed to fast for >10 h before arrival to the laboratory for the high-fat meal consumption and subsequent blood sampling, record and replicate the same dietary intake for 24 h before the laboratory procedure, abstain from caffeine and dietary supplements for 24 h before the laboratory procedure, and wake between 06:00 and 07:00 prior to each laboratory trial. Participants were instructed to abstain from exercise training for 1 week prior to testing.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Postprandial triglyceride levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
2. Postprandial insulin levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
3. Postprandial glucose levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
4. Postprandial non-esterified fatty acid levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
5. Postprandial high-density lipoprotein (HDL) levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
6. Postprandial low-density lipoprotein (LDL) levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8

Secondary outcome measures

1. Inflammatory marker (high-sensitivity C-reactive protein [hs-CRP], IL-6, monocytes, macrophages, leukocytes) levels in blood taken at 0.75, 2, 4 and 6 h after a high-fat meal on days 1 and 8
2. Activity profiles recorded during each football training session using a wGT3X-BT actigraph placed on the hip and calculated using the integrated tri-axial accelerometer Freedson vector magnitude equation
3. Subjective rating of perceived exertion assessed within 10 min of completing the training by participants verbally provided their exertion level of the training intervention on the Borg CR10 scale

Overall trial start date

01/08/2014

Overall trial end date

26/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy males
2. Recreationally active
3. Written consent obtained following detailed instructions by the principal investigator

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Cardiovascular, pulmonary or metabolic disease
2. Contraindications to exercise testing as established by the American College of Sports Medicine
3. Dietary restrictions regarding the meal provided

Recruitment start date

01/06/2018

Recruitment end date

01/08/2018

Locations

Countries of recruitment

Qatar

Trial participating centre

Aspetar Orthopaedic and Sports Medicine Hospital
Sports City Zone
Doha
29222
Qatar

Sponsor information

Organisation

Aspetar Orthopaedic and Sports Medicine Hospital

Sponsor details

Sports City Zone
Doha
29222
Qatar
00974 44132988
ADLQ-RO@adlqatar.com

Sponsor type

Hospital/treatment centre

Website

http://www.aspetar.com/index.aspx?lang=en

Funders

Funder type

Government

Funder name

Qatar Foundation

Alternative name(s)

Qatar Foundation for Education, Science and Community Development

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Qatar

Results and Publications

Publication and dissemination plan

The researchers intend to publish in a scientific research article and presentation.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review. 06/03/2019: Trial's existence confirmed by Anti-Doping Lab Qatar Institutional Review Board.