- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229345
Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition
May 2, 2012 updated by: Javier Gonzalez, Northumbria University
The Interactive Effect of Breakfast Consumption and Exercise on Metabolism, Appetite and Cognitive Function
The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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, NE1 8ST
- Brain, Performance and Nutrition Centre, Northumbria University
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Aged 18-45 years
- BMI 18.5-24.9 kg/m2
- Physically active: able to run for 1 h at a moderate pace
- Healthy
Exclusion Criteria:
- Smokers
- Food allergies
- Metabolic disorders
- Restrained eaters (equivalent of >7 for restrained on TFEQ)
- Consuming herbal/dietary supplements
- History of head trauma
- Learning difficulties
- ADHD
- Dyslexia
- History of migraines
- Gastric problems
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Breakfast & exercise
|
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
|
|
Experimental: Breakfast & no exercise
|
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
|
|
Experimental: No breakfast & exercise
|
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
|
|
No Intervention: No breakfast & no exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy balance
Time Frame: 24 h
|
Energy balance (kJ/kcal) will be assessed by an ad libitum test meal provided at 5 h minus energy expenditure estimated by indirect calorimetry.
|
24 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack
|
1.5 h area under the curve, post-consumption of a liquid snack
|
|
|
Serum insulin
Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack
|
1.5 h area under the curve, post-consumption of a liquid snack
|
|
|
Subjective appetite ratings
Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
Participants will be asked to complete visual analogue scales (VAS).
|
1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
|
Cognitive function measurements
Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
Reaction time, short-term memory, speed of processing, attention.
|
1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
|
Mood
Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
Participants will be asked to complete visual analogue scales (VAS).
|
1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
|
|
Energy expenditure
Time Frame: 1.5 h mean following a liquid snack
|
Measured by indirect calorimetry
|
1.5 h mean following a liquid snack
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emma J Stevenson, PhD, 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
October 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 26, 2010
First Posted (Estimate)
October 27, 2010
Study Record Updates
Last Update Posted (Estimate)
May 4, 2012
Last Update Submitted That Met QC Criteria
May 2, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 32W3
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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