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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01229345
Other study ID # 32W3
Secondary ID
Status Completed
Phase N/A
First received October 12, 2010
Last updated May 2, 2012
Start date October 2010
Est. completion date July 2011

Study information

Verified date May 2012
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Breakfast & exercise
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.

Locations

Country Name City State
United Kingdom Brain, Performance and Nutrition Centre, Northumbria University Newcastle Upon Tyne Tyne and Wear

Sponsors (1)

Lead Sponsor Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy balance 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 No
Secondary Blood glucose 1.5 h area under the curve, post-consumption of a liquid snack No
Secondary Serum insulin 1.5 h area under the curve, post-consumption of a liquid snack No
Secondary Subjective appetite ratings 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 No
Secondary Cognitive function measurements 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 No
Secondary Mood 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 No
Secondary Energy expenditure Measured by indirect calorimetry 1.5 h mean following a liquid snack No