CompletedPhase 3ACTRN12615000062527

A randomised, double-blind, placebo-controlled, crossover trial investigating the effects of two nutraceutical combination formulas on mental fatigue, mood and neurocognitive performance in healthy adults.


Sponsor

Swinburne University of Technology

Enrollment

30 participants

Start Date

Jan 14, 2015

Study Type

Interventional

Conditions

Summary

The primary purpose of this study is to evaluate whether acute supplementation with either of two nutraceutical combination formulas (ErgGo Mom and ErgGo POP), relative to placebo, reduces self-rated mental fatigue associated with performing cognitively demanding tasks.


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Healthy adults aged 20 to 50 years

Exclusion Criteria7

  • Participant experiences or evidence of delirium, confusion, or other disturbance of consciousness.
  • Participant has any diagnosed illness or disorder affecting cognitive function or mood such as depression, anxiety, stroke or dementia.
  • Individuals currently taking prescription medication other than a contraceptive pill.
  • Any significant concurrent illness including any bleeding disorders, coronary heart disease, diabetes, gastrointestinal disorder.
  • Any known or suspected food allergies (this would cover all ingredients in the investigational product).
  • Participant has a recent history of (within 12 months of V1) or strong potential for alcohol or substance abuse.
  • Participant is a female, who is pregnant, planning to be pregnant during the study period, or lactating.

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Interventions

Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products). Participants will consume a different treatment each testing day. Each

Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products). Participants will consume a different treatment each testing day. Each product consists of a powdered drink mix, which is to be dissolved in 500ml of water prior to consumption. The intervention will be consumed at the testing centre by healthy volunteers while under researcher supervision The following products will be investigated: ErgGo MOM contains: Green tea extract (130mg including 13mg of caffeine) Quercetin (100mg) Enzogenol (50mg) Magnesium (50mg) L-Theanine (25mg) Niacin (20mg) Vitamin B6 (2mg) Vitamin B12 (400mcg) Maltodextrin plus stevia (sweetener) and natural flavour/colour Citric Acid, Gum Acacia, Guar Gum, Xanthan Gum ErgGo POP contains: DMAE (dimethylaminoethanol, 200mg) Green tea extract (130mg including 13mg of caffeine) Quercetin (100mg) Caffeine (87mg) Enzogenol (50mg) Magnesium (50mg) L-Theanine (25mg) Niacin (20mg) Vitamin B6 (2mg) Vitamin B12 (400mcg) Maltodextrin plus stevia (sweetener) and natural flavour/colour Citric Acid, Gum Acacia, Guar Gum, Xanthan Gum


Locations(1)

VIC, Australia

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ACTRN12615000062527