Clinical TrialID 1029
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
NCT03689348
Cognitive Change|Stress, Psychological|Mood
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Record Fields
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- Clinical Trial Id
- 1029
- Evidence Id
- 1029
- Core Evidence Id
- 1029
- Source Clinical Trial Id
- 1011
- Herb2 Clinical Trial Id
- HBCT001011
- Nct Id
- NCT03689348
- Title
- Acute and Chronic Effects of Avena Sativa on Cognition and Stress
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Cognitive Change|Stress, Psychological|Mood
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
- Intervention
- DIETARY_SUPPLEMENT: Avena sativa|DIETARY_SUPPLEMENT: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Other
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 132
- Outcome Measure
- Changes in mood; as assessed by the 'Profile Of Mood States' (POMS), Mood will be assessed with the profile of mood states questionnaire questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups., Pre-dose and post-dose on day 1 and day 29|Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire, Mood will be assessed with the general anxiety disorder-7 questionnaire on day 1 and then again on day 8, 15, 22 and 29 of the study intervention period. Change from baseline scores will be calculated and, at each subsequent time point, scores will be compared across the x4 treatment groups to ascertain if the IP has changed mood., Day 1, 8, 15, 22 and 29|Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ), Mood will be assessed with the general health questionnaire and this will be completed at the start and end of the testing day on day 1 and day 29. To assess if the investigational product (IP) has changed mood a change score will be calculated (end of day minus start of day) and this will be compared between the x4 treatment groups., Pre-dose and post-dose on day 1 and day 29|Changes in cognitive function, Cognitive function will be assessed via several individual cognitive tasks (stroop, rapid visual information processing and corsi blocks) and will together provide indicators of accuracy and speed. This data will be collected at baseline, 120- and 240-minutes post-dose on day 1 and day 29. Change from baseline scores will be calculated and compared across the x4 treatment groups to ascertain if the IP has changed cognitive function., Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in subjective stress; as assessed by the 'perceived stress scale' (PSS), Subjective stress will be measured via the perceived stress scale before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress., Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI), Subjective stress will be measured via the state, trait anxiety inventory before and after each completion of the observed multitasking stressor (OMS) on day 1 and on day 29. The change in the stress response between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed subjective perceptions of stress., Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in objective stress; as assessed by salivary cortisol levels, Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary cortisol levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response, Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in objective stress; as assessed by salivary alpha-amylase levels, Saliva samples will be taken from participants before and after each completion of the observed multitasking stressor (OMS) and the change in salivary alpha amylase levels between pre- and post-OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response, Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in objective stress; as assessed by galvanic skin response (GSR), Galvanic skin response (GSR) will be recorded throughout the observed multitasking stressor (OMS) and the change in GSR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response, Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29|Changes in objective stress; as assessed by heart rate (HR), Heart rate (HR) will be recorded throughout the observed multitasking stressor (OMS) and the change in HR across the OMS will be compared across the x4 treatment groups to ascertain if the IP has changed the objective stress response., Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
- Sponsor Collaborator
- Northumbria University|Anklam Extrakt
- Funded By
- OTHER
- Location
- Northumbria University, Newcastle Upon Tyne, NE1 8ST, United Kingdom
- Other Id
- 57BV1
- Start Date
- 2018-09-24
- Primary Completion Date
- 2019-09-24
- Completion Date
- 2019-09-24
- First Posted
- 2018-09-28
- Results First Posted
- Last Update Posted
- 2020-03-17
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/48/NCT03689348/Prot_SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03689348
- Title Cn
- Title En
- Acute and Chronic Effects of Avena Sativa on Cognition and Stress
- Bilingual Status
- semi_complete