The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition

NCT01929694 | Completed Phase 4

• 1 other identifier: 9B2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Affect and Exertion During and Post-exercise

Outcome Measures

Primary Outcomes (1)

• Affect

  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 Outcomes (1)

• Exertion

  Measured at 10min intervals during exercise

Other Outcomes (3)

• Cognitive Function

  Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise

• Mood

  Assessed at baseline, pre-exercise and immeadiately and 75min post-exercise

• Substrate Metabolism

  Measured at 10min intervals during exercise

Study Arms (2)

Berocca Boost

ACTIVE COMPARATOR

Guarana and vitamin and mineral complex, one tablet dissolved in 250ml water taken once.

Dietary Supplement: Berocca Boost

Placebo

PLACEBO COMPARATOR

Matched placebo tablet, one tablet dissolved in 250ml water taken once.

Dietary Supplement: Placebo

Interventions

Berocca Boost DIETARY_SUPPLEMENT

Berocca Boost

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Bayer: collaborator

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria Univerity

Newcastle upon Tyne, Tyne and Wear, NE18ST, United Kingdom

Location

Study Officials

• Rachel Veasey, MSc

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 28, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

GB (1)