NCT01711008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

September 25, 2012

Last Update Submit

April 30, 2013

Conditions

Alteration of Cognitive Function

Keywords

Breakfast sizeExerciseCognitive performanceMoodAppetiteActive women

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Mood change from baseline scores

    Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours

Other Outcomes (1)

  • Appetite change from baseline scores

    Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours

Study Arms (3)

No Breakfast

PLACEBO COMPARATOR

Water only

Dietary Supplement: No breakfast

20g Cereal

ACTIVE COMPARATOR

20g Kelloggs Special K cereal with 83ml semi-skimmed milk

Dietary Supplement: Cereal

40g Cereal

ACTIVE COMPARATOR

40g Kelloggs Special K cereal with 166ml semi-skimmed milk

Dietary Supplement: Cereal

Interventions

CerealDIETARY_SUPPLEMENT
Also known as: Breakfast cereal
20g Cereal40g Cereal
No breakfastDIETARY_SUPPLEMENT
No Breakfast

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria Univerity

Newcastle upon Tyne, Tyne and Wear, NE19ST, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Edible Grain

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Crops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Officials

  • Rachel Veasey

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 19, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

GB(1)