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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01711008
Other study ID # 29W5
Secondary ID
Status Completed
Phase N/A
First received September 25, 2012
Last updated April 30, 2013
Start date September 2012
Est. completion date March 2013

Study information

Verified date April 2013
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cereal

No breakfast


Locations

Country Name City State
United Kingdom Brain, Performance and Nutrition Research Centre, Northumbria Univerity 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
Other Appetite change from baseline scores 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 No
Primary Cognitive function change from baseline scores 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 No
Secondary Mood change from baseline scores 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 No
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