Pilot:To investigate whether there is a significant difference in variability of performance on attention tests between the pilot and previous studies conducted by Unilever.Hoofdonderzoek: To show that black tea improves attention using attention…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alertheid, concentratie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pilot:
To investigate whether there is a significant difference in variability of
performance on attention tests between the pilot and previous studies conducted
by Unilever.
Hoofdonderzoek:
To show that black tea improves attention using attention tests.
Secondary outcome
Not applicable.
Background summary
Tea is the second most widely consumed beverage in the world only being
surpassed by water. It has been historically associated with enhanced
concentration, which refers to the psychological concept of attention.
Study objective
Pilot:
To investigate whether there is a significant difference in variability of
performance on attention tests between the pilot and previous studies conducted
by Unilever.
Hoofdonderzoek:
To show that black tea improves attention using attention tests.
Study design
Pilot:
16 Healthy males and females will participate. The study will consist of 1
screening and 1 visit.
Hoofdonderzoek:
40 Healthy males and females will participate. The study will consist of 1
screening and 4 visits.
Study burden and risks
The risks associated with this investigation are minimal. The burden on the
volunteer will continue to work with the recording periods, and assessments
preformed during the study. All volunteers are closely monitored and supervised
by experienced doctors and studystaff.
Olivier van Noortlaan 120
PO Box 114, 3130 AC Vlaardingen
NL
Olivier van Noortlaan 120
PO Box 114, 3130 AC Vlaardingen
NL
Listed location countries
Age
Inclusion criteria
1) Male and female participants in the age 18 - 50 at start of the study;
2) Weight range for males: 85 kg +/- 10 kg; Weight range for females: 65 kg +/- 10 kg;
3) BMI: 20.0 - 30.0 kg/m2;
4) Healthy
5) Alcohol consumption for females < 14 units/week and males < 21 units/week;
6) Informed consent signed;
7) Having a general practitioner (GP);
8) Capable of performing cognitive tests on a computer (performance > 50%;
9) Proficient in Dutch language (and able to understand written instructions);
10) Consumes caffeine (3 cups of either tea, cola or coffee per week minimum) maximum of 21 cups per week to avoid withdrawal effects.
Exclusion criteria
1) Being an employee of Unilever or the CRO;
2) Not usually having breakfast in the morning;
3) Currently on a medically prescribed or slimming diet;
4) Undergoing medical treatment that may interfere with the study outcome as assessed by the research physician;
5) Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study;
6) Use of systemic antibiotics in the period of 3 months prior to the study;
7) Intense exercise >10 h/w;
8) Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination;
9) Reported participation in another biomedical trial 3 months before the start or before last dosing;
10) The habit of smoking during the past 6 months or using nicotine containing products during the past month;
11) Reported participation in night shift work (1 week before screening and during the study);
12) Colour-blindness or self-reported dyslexia;
13) Participation in pilot study (only for main study).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33009.056.10 |