- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929694
The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition
October 2, 2014 updated by: Northumbria University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE18ST
- Brain, Performance and Nutrition Research Centre, Northumbria Univerity
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Berocca Boost
Guarana and vitamin and mineral complex, one tablet dissolved in 250ml water taken once.
|
|
Placebo Comparator: Placebo
Matched placebo tablet, one tablet dissolved in 250ml water taken once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affect
Time Frame: Assessed pre-exercise, at 10min intervals during exercise and 45 and 75min post-exercise
|
Affect measured using the Feeling Scale and Felt Arousal Scale
|
Assessed pre-exercise, at 10min intervals during exercise and 45 and 75min post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exertion
Time Frame: Measured at 10min intervals during exercise
|
Rate of perceived exertion measured using the Borg scale
|
Measured at 10min intervals during exercise
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function
Time Frame: Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
|
Participants will complete a set of cognitive tasks (Immediate Word Recall, Choice Reaction Time, Rapid visual information processing task, Numeric Working Memory, Delayed word Recall, Word Recognition and Picture Recognition) measuring episodic memory, working memory, attention and decision making.
|
Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
|
Mood
Time Frame: Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
|
Assessed using the Bond-Lader Visual Analogue Scales (VAS) and Energy VAS (concentration, physical stamina, mental stamina)
|
Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise
|
Substrate Metabolism
Time Frame: Measured at 10min intervals during exercise
|
Measured using an online gas analysis system (Cortex).
Oxygen uptake, carbon dioxide production, fat and carbohydrate oxidation and energy expenditure will be measured for 1 min at each 10min interval.
|
Measured at 10min intervals during exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel Veasey, MSc, Northumbria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 21, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
October 2, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 9B2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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