Affect and Exertion During and Post-exercisePhase 4NCT01929694
The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition
A Phase 4 study testing Berocca Boost in people with Affect and Exertion During and Post-exercise, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Affect and Exertion During and Post-exercise
- What is being tested?
- Berocca Boost
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre, Northumbria Univerity
Newcastle upon Tyne, Tyne and Wear, NE18ST
About this study
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
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.
- Being tested
- Berocca Boost, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berocca BoostDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Berocca Boost | Active comparator | Guarana and vitamin and mineral complex, one tablet dissolved in 250ml water taken once. Receives: Dietary Supplement: Berocca Boost |
| Placebo | Placebo comparator | Matched placebo tablet, one tablet dissolved in 250ml water taken once. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect
Affect measured using the Feeling Scale and Felt Arousal Scale
Measured: Assessed pre-exercise, at 10min intervals during exercise and 45 and 75min post-exercise
Secondary outcomes (1)
Exertion
Rate of perceived exertion measured using the Borg scale
Measured: Measured at 10min intervals during exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affect and Exertion During and Post-exerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Rachel Veasey, MSc, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929694
- Sponsor's protocol ID
- 9B2
- Status last verified
- Oct 2014
- First submitted
- 19 Aug 2013
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01929694
- Acronym / sponsor ID
- 9B2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berocca Boost | Active comparator | Dietary Supplement: Berocca BoostGuarana and vitamin and mineral complex, one tablet dissolved in 250ml water taken once. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched placebo tablet, one tablet dissolved in 250ml water taken once. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berocca Boost | Dietary supplement | Berocca Boost |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
Exertion
Time frame: Measured at 10min intervals during exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Recruiting
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Affect and Exertion During and Post-exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Veasey, MSc principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Berocca Boost in people with Affect and Exertion During and Post-exercise, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affect (time frame: Assessed pre-exercise, at 10min intervals during exercise and 45 and 75min post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.