- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01711008
The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women
April 30, 2013 updated by: Rachel Veasey, Northumbria University
The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite Later in the Day in Habitually Active Women
Both regular exercise and breakfast consumption have well known health benefits.
Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day.
The purpose of this study is to test whether the amount of food consumed at breakfast prior to exercise influences these parameters in active women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE19ST
- Brain, Performance and Nutrition Research Centre, Northumbria Univerity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Must be habitually active (exercising for least 30 minutes, 3 times per week for at least the previous 6 months)
- Must have a normal exercise routine includes a minimum of 1 morning exercise session (which takes place between 6am-11am) each week
- Must run on a regular basis (at least once per week) and be able to run at a moderate pace for 30 minutes non-stop on a treadmill
- Must consume breakfast on most days of the week, usually consume breakfast before undertaking a morning exercise session and be comfortable consuming a bowl of cereal 45mins before running
Exclusion Criteria:
- English not first language
- Smoking
- Previous or current eating disorders, metabolic disorders, gastric problems or any contraindications of exercise.
- Pregnancy
- The habitual use of some prescription or over the counter medications (excluding contraception) or herbal/dietary supplements (please ask the researcher)
- A history of or current learning difficulties, ADHD or dyslexia
- Daily use of an inhaler to control asthma
- Allergies or intolerances to any of the foods provided in the study (Special K cereal, semi-skimmed milk, pasta, tomato sauce, cheese, olive oil, rice, custard)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: No Breakfast
Water only
|
|
|
Active Comparator: 20g Cereal
20g Kelloggs Special K cereal with 83ml semi-skimmed milk
|
Other Names:
|
|
Active Comparator: 40g Cereal
40g Kelloggs Special K cereal with 166ml semi-skimmed milk
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function change from baseline scores
Time Frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Participants will complete 4 cognitive tasks (Four Choice Reaction Time, NBack, Stroop and RVIP) measuring reaction time, short-term memory, speed of processing and attention.
|
Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood change from baseline scores
Time Frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Mood will be assessed using Visual Analogue Scales (VAS) immediately before and after each set of cognitive tasks.
|
Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite change from baseline scores
Time Frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Appetite will be assessed using Visual Analogue Scales (VAS) immediately before each set of cognitive tasks.
|
Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rachel Veasey, Northumbria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
September 25, 2012
First Submitted That Met QC Criteria
October 18, 2012
First Posted (Estimate)
October 19, 2012
Study Record Updates
Last Update Posted (Estimate)
May 1, 2013
Last Update Submitted That Met QC Criteria
April 30, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 29W5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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