Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/12/2018
Date assigned
11/12/2018
Last edited
05/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is a growing amount of literature committed to understanding if being more active will have beneficial effect on health. However, less is known on whether performing exercise twice a day is more beneficial than exercising once when matched for workload. Therefore, the aim of this study is to identify if workload matched exercise split over the day, will result in possible changes in gastrointestinal function, metabolic responses and appetite.

Who can participate ?
Healthy males (age 18-40 years; body mass index <29.9 kg/m2; non-smokers, no history of GI symptoms not consuming prescription medication and subsequently be physically active, in order to complete the trials.

What are the possible benefits and risks of participating?
1. Full fitness assessment
2. Information about the participants diet
3. Knowledge about how gastric emptying may affect exercise
4. Experience within a research laboratory

What does the study involve?
The study involves two non-consecutive test days in a randomised order. After a 24 hour standardisation period and overnight fast. Participants come to the laboratory and exercise; either split over the day (two, 30min cycles) or a one-off bout (60-min cycle) before consuming a milk-shake and a standardised semi-solid meal. Throughout the trial, measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and 24-hour energy intake. Blood samples will also be taken regularly throughout the trials.

Where is the study run from?
Manchester Metropolitan University , Manchester (UK)

Who is funding the study?
Manchester Metropolitan university

When is the study starting and how long is it expected to run for?
December 2018 to September 2019

Who is the Main Contact?
Mr Lewis Mattin
l.mattin@mmu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gethin Evans

ORCID ID

Contact details

School of Healthcare Science
Manchester Metropolitan University
Chester Street
Manchester
M1 5GD
United Kingdom
01612471208
gethin.evans@mmu.ac.uk

Type

Public

Additional contact

Mr Lewis Mattin

ORCID ID

Contact details

School of Healthcare Science
Manchester Metropolitan University
Chester Street
Manchester
M1 5GD
United Kingdom
01612471215
l.mattin@mmu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LRM-1089

Study information

Scientific title

The effect of exercising once vs. twice a day on gastrointestinal function, metabolic responses and appetite in healthy males: a randomised cross over trial.

Acronym

Split exercise

Study hypothesis

1. Exercising twice a day will result in differences in gastric emptying rate and metabolic responses compared to a single workload-matched bout of exercise.
2. Exercising twice a day will result in differences in appetite and gut hormone responses compared to a single workload-matched bout of exercise.

Ethics approval

The Faculty of Science and Engineering Research Ethics and Governance Committee at Manchester Metropolitan University, 11/2018, ref. 1089

Study design

Interventional, repeated measures with randomised crossover

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format please use contact details to request a participants information sheet

Condition

Obesity

Intervention

Participants will complete two 7h experimental trials in a randomised cross-over design, where each participant will complete both trial arms; exercise once and twice a day separated by a minimum of 7 days. One trial will consist of a one off 60-min cycle at 70% peak maximal oxygen uptake. After completion of this single bout of exercise, participants will ingest a milkshake containing 30% of their estimated energy expenditure through the trial. Following a rest period the remaining 70% of their estimated energy expenditure through the trial will be provide as a semi-solid meal. The second trial will consist of a 30-min cycle before participants will ingest a milkshake followed by the same rest period before completing the remaining 30-min cycle and ingestion of a semi-solid meal. There will be no follow up session apart from all participant will record 24-h food intake following both trials.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test . Breath samples will be collected at baseline and every 15min for a two-hour period.
2. Circulating levels of key gut hormones and metabolic markers. Blood samples will be collected at baseline, pre-milkshake, 1h-post milkshake, 2h-post milkshake, pre-semi-solid meal ingestion, 1-h post meal ingestion and 2h post meal ingestion
3. Substrate oxidation will be measured using a breath-by breath gas analyser at rest, during exercise sessions and every 30 min post food ingestion for 2h
4. Visual analogue scales will be used to measure subjective sensations of appetite at rest, pre-meal ingestion and every 30min post food ingestion for 2h.
5. 24h post trial energy intake using weighed food intake dietary record

Secondary outcome measures

1. Ratings of perceived exertion using the Borg scale and heart rate will be recorded pre exercise and every 15min during exercise

Overall trial start date

26/07/2018

Overall trial end date

30/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy males
2. Age between 18-40 years
3. Body mass index = <29.9 kg/m2
4. Non-smokers
5. No history of GI symptoms
6. Not consuming prescription medication, or no other relevant medical conditions assessed by a medical screening questionnaire.
7. Subsequently be physically active, in order to complete the trials.

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

14 participants

Total final enrolment

16

Participant exclusion criteria

1. Lactose Intolerant
2. Vegan

Recruitment start date

17/12/2018

Recruitment end date

10/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Metropolitan University
John Dalton Building School of Healthcare Science Chester Street
Manchester
M1 5GD
United Kingdom

Sponsor information

Organisation

Manchester Metropolitan University

Sponsor details

School of Healthcare Science
Faculty of Sciences and Engineering
Chester Street
Manchester
M1 5GD
United Kingdom
01612472818
Justine.Daniel@mmu.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Manchester Metropolitan University

Alternative name(s)

MMU

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned communication of results at a scientific conference .
Planned publication in a high impact peer reviewed journal within 12 months of the completion of the study

IPD sharing statement: participant level data is not expected to be available as this complies with the conditions of the ethical approval grated for this study.

Intention to publish date

30/08/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/09/2019: The following changes have been made: 1. The recruitment end date has been changed from 31/08/2019 to 10/04/2019. 2. The overall trial end date has been changed from 30/09/2019 to 30/08/2019. 3. The intention to publish date was changed from 20/05/2020 to 30/08/2020. 4. The final enrolment number was added. 18/12/2018: Internal review.