Clinical trial NCT01929694: The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition
Official title: The Effect of Consuming a Guaraná and Vitamin and Mineral Complex Before a Morning Exercise Session on Affect, Exertion and Substrate Metabolism During Exercise and Cognitive Performance During the Post-exercise Recovery Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Affect and Exertion During and Post-exercise
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2013-08-28
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive function at rest; guaraná also contains caffeine, which can reduce perceived exertion and increase fat burning during exercise. The purpose of this study is to test whether consuming a guaraná and vitamin and mineral product before exercise influences affect (mood), physical exertion and fat burning during exercise and mental fatigue, cognitive performance and affect post-exercise.


Eligibility criteria: Inclusion Criteria:

Individuals must be:

* Healthy
* Male
* Aged between 18 and 35years
* Habitually active (exercising at least twice a week)
* Able to run at a moderate pace for 30 minutes non-stop on a treadmill

Exclusion Criteria:

Individuals will not be eligible to take part in this study if they:

* have a history of neurological or psychiatric diseases excluding anxiety or depression
* have a current diagnosis of depression or anxiety
* have a history of significant head trauma, metabolic, endocrine or cardiac disorders
* have smoked within the last 3 months,
* have high blood pressure \>140/90mmHg
* consume \> 500 mg caffeine per day from all dietary sources
* have adverse reactions to caffeine containing products (i.e. tea, coffee, energy drinks, cola, Pepsi)
* are currently taking any pharmaceuticals
* have habitual taken dietary supplements within the last 4 weeks (defined as ≥3 consecutive days or ≥4 days in total per week)
* have current or history of drug or alcohol abuse
* have participated in another clinical trial within 30 days prior to screening
* have any condition which may interfere with your ability to perform assessments
* have any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance

Primary outcomes:
measure: Affect
timeFrame: Assessed pre-exercise, at 10min intervals during exercise and 45 and 75min post-exercise
Secondary outcomes:
measure: Exertion
timeFrame: Measured at 10min intervals during exercise
Other outcomes:
measure: Cognitive Function
timeFrame: Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
measure: Mood
timeFrame: Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
measure: Substrate Metabolism
timeFrame: Measured at 10min intervals during exercise
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre, Northumbria Univerity
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Rachel Veasey, MSc
role: PRINCIPAL_INVESTIGATOR
References: