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Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, Northumbria University
ClinicalTrials.gov Identifier:
NCT01229345
First received: October 12, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Energy Balance,
Appetite,
Cognitive Function.
 Drug: Breakfast & exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Interactive Effect of Breakfast Consumption and Exercise on Metabolism, Appetite and Cognitive Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Energy balance [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    Energy balance (kJ/kcal) will be assessed by an ad libitum test meal provided at 5 h minus energy expenditure estimated by indirect calorimetry.


Secondary Outcome Measures:
  • Blood glucose [ Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Participants will be asked to complete visual analogue scales (VAS).

  • 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 ] [ Designated as safety issue: No ]
    Reaction time, short-term memory, speed of processing, attention.

  • Mood [ Time Frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal ] [ Designated as safety issue: No ]
    Participants will be asked to complete visual analogue scales (VAS).

  • Energy expenditure [ Time Frame: 1.5 h mean following a liquid snack ] [ Designated as safety issue: No ]
    Measured by indirect calorimetry


Enrollment: 12
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breakfast & exercise Drug: Breakfast & exercise
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
Experimental: Breakfast & no exercise Drug: Breakfast & exercise
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
Experimental: No breakfast & exercise Drug: Breakfast & exercise
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
No Intervention: No breakfast & no exercise

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229345

Locations
United Kingdom
Brain, Performance and Nutrition Centre, Northumbria University
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Emma J Stevenson, PhD Northumbria University
  More Information

No publications provided

Responsible Party: Javier Gonzalez, PhD Student, Northumbria University
ClinicalTrials.gov Identifier: NCT01229345     History of Changes
Other Study ID Numbers: 32W3
Study First Received: October 12, 2010
Last Updated: May 2, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013