An investigation into the cognitive effects and bioavailability of components of green tea.

Phase 4

Completed

• Conditions: Cognitive function in healthy adults.; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12612000389808
• Lead Sponsor: GlaxoSmithKline Nutritional Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-04
• Study Completion: 2014-01-06
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

People who meet the following inclusion criteria will be included in the trial:
1. Male or female.
2. Aged 18-40 years.
3. Willing and able to provide written informed consent.
4. Understands and is willing and able to comply with all study procedures.
5. Are in good general health with no history of psychiatric disease.
6. Regular caffeine consumers (between 1-4 cups of coffee per day most days)
7. Must have corrected to normal vision

Exclusion Criteria

Subjects who display any of the following will be excluded from the trial:
1.Females who are pregnant/lactating and/or not using a medically approved form of contraception.
2. Any significant concurrent illness including any bleeding disorders, heart conditions, diabetes, glaucoma, high blood pressure or osteoporosis.
3. Individuals who suffer from Diabetes Mellitus or diagnosed with Phenylketonuria (PKU).
4. Any known or suspected food allergies (this would cover all ingredients in the investigational product).
5. Susceptible to any unwanted side-effects of caffeine, such as reduction in sleep quality.
6. Smokers and users of recreational drugs (except alcohol and other food grade actives)
7. Have participated in any other study involving an investigational product in the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Performance using computerised measures aimed at evaluating attentional processes.[Baseline, 30 minutes post treatment and 120 minutes post treatment.];Mood as assessed by the following questionnaires:<br><br>Bond&Lader Visual analogue mood scales <br>Caffeine Research Visual Analogue scales<br>Stress and Fatigue Visual Analogue Mood Scales (VAMS)[Baseline, 50 minutes post treatment and 140 minutes post treatment.]

Secondary Outcome Measures

Name	Time	Method
Serum levels of catechins and caffeine to assess the relationship between any behavioural change and levels of active components of green tea extract. <br><br>These levels will be measued by analysing venous blood collected via a vacutainer following standard phlebotomy procedures.[Baseline and 148 minutes post treatment]