The Focus of the Study is Healthy Volunteers Clinical Trial
— Reactivi-TeaOfficial title:
Quantifying the Effects of Daily Tea Consumption on Cognition, Sleep, and Mood, and Understanding Individual Characteristics That Affect Responses: a Series of N-of-1 Studies
The goal of these series of N-of-1 trials is to compare the effects of three tea interventions on cognition, mood, and sleep, in healthy adult participants. The main questions they aim to answer are: - What are the short-term effects of, and differences between, three different black tea interventions on cognition, mood, and sleep, in individual participants? - What are the short-term effects of, and differences between, three different green tea interventions on cognition, mood, and sleep, in individual participants? - Are there any other lifestyle factors that influence the relationship between tea intake and cognition, mood, or sleep, and to what extent do they have an effect? Participants will be asked to drink three different tea interventions in four blocks of three weeks, where each week is assigned one tea intervention. At regular intervals three times per day, seven days per week, for the 12-week study duration, participants will be asked to complete a sleep questionnaire, mood questionnaire, personalised questionnaire (with questions pertaining to physical activity and work, for example), a tea consumption recall questionnaire, and two cognitive tasks based on attention (lasting one minute each). These questionnaires and tasks comprise one measurement point and take approximately five to six minutes to complete.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People that speak English - People that possess a computer, tablet, or smartphone that they can access regularly throughout any day of the week. Exclusion Criteria: - A current clinical diagnosis of Alzheimer's disease - A current clinical diagnosis of Parkinson's disease - A current clinical diagnosis of dementia - A current clinical diagnosis of any other brain disease - A current clinical diagnosis of cognitive impairment - A current clinical diagnosis of any mood disorder - People with any food allergies - Pregnant or breastfeeding women. |
Country | Name | City | State |
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United Kingdom | The Rowett Institute | Aberdeen | Aberdeenshire |
Lead Sponsor | Collaborator |
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University of Aberdeen | Lipton Teas and Infusions |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
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Primary | The cognitive domain 'attention' measured using mean reaction time and accuracy in the attention switching task | Participants will be presented with consecutive pairs of semi-random (a random pair from the pre-defined groups with lagged replacement, i.e., a character in one pair cannot be present in the following pair) alphanumeric characters; each pair being displayed for one second. Each pair will consist of one letter (A, E, I, U, G, K, M, R) and one number (2, 3, 4, 5, 6, 7, 8, 9), in either font colour red or purple. One character will be to the left, and one to the right, of a central fixation cross; there is equal probability of the letter or number appearing on either side. The font colour changes every three pairs. No letter or number will appear in consecutive pairs. A response is made by pressing the spacebar or tapping the screen. The two conditions for a participant to respond are: if the font colour is red and the letter is a vowel; the font colour is purple, and the number is even. In other conditions, participants should withhold from responding. The task will last one minute. | From enrolment to the end of the final tea intervention. This is the total study duration of 12 weeks. | |
Primary | The cognitive domain 'attention' measured using mean reaction time and accuracy in the digit vigilance task | Participants will be shown two streams of numbers, one of the pair on the left of the screen, and one on the right. The number on the right is the target digit and the number on the left is the random digit. The target digit is a random number between 1 and 9 that is constant for the duration of the test but random at every test occasion, and the random number stream displays random numbers between 1 and 9, consecutively, for 0.75 seconds each. No two consecutive random numbers are the same. Participants should respond by pressing the spacebar on a computer, or tapping the screen on a mobile phone or tablet, as quickly as possible, when the random digit matches the target digit. The task will last one minute and a total of 15 matches will be displayed. | From enrolment to the end of the final tea intervention. This is the total study duration of 12 weeks. | |
Secondary | Mood attributes measured using the Caffeine Research Visual Analogue Scale | The following mood outcomes are each assessed using a visual analogue scale of 0 to 100: relaxed, alert, jittery, tired, tense, headache, mentally fatigued, overall mood. Two additional mood adjectives were added: calm, energetic. | From enrolment to the end of the final tea intervention. This is the total study duration of 12 weeks. | |
Secondary | Sleep attributes measured using components of the Leeds Sleep Evaluation Questionnaire and sleep and wake times | All participants will be asked four questions to assess their sleep. Two are from the Leeds Sleep Evaluation Questionnaire: 'How does the way you fell asleep last night compare with how you usually fall asleep?' answered using three visual analogue scale prompts: 1. 'Harder than usual' ? 'Easier than usual', 2. 'Slower than usual' ? 'Faster than usual', 3. 'I felt less drowsy than usual' ? 'I felt more drowsy than usual'; 'How does your quality of sleep last night compare with your usual quality of sleep?' answered using two visual analogue scale prompts, 1. 'More restless than usual' ? 'Calmer than usual', 2. 'More periods of wakefulness' ? 'Fewer periods of wakefulness'. The other two questions concern sleep and wake times: 'What time did you turn off your light before going to sleep last night?'; 'What time did you wake up this morning?' These four questions will only be asked at the first measurement point of each test day. | From enrolment to the end of the final tea intervention. This is the total study duration of 12 weeks. |
Status | Clinical Trial | Phase | |
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Completed |
NCT02090049 -
Appetite Regulation by a Breakfast Soft Bread
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N/A |