Back to resultsAcute and Chronic Effects of Avena Sativa on Cognition and Stress
Primary Purpose
Cognitive Change, Stress, Psychological, Mood
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Avena sativa
Placebo
Sponsored by
About this trial
This is an interventional other trial for Cognitive Change
Eligibility Criteria
Inclusion Criteria:
- Participants must self-assess themselves as being in good health
- Aged 35 to 65 years at the time of giving consent
- In employment and/or higher education or full time child-care
Exclusion Criteria:
Participants are not eligible to take part if they:
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progess to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to impede the participant's ability to perform the study assessments, participants may be able to progress to screening.
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- If still menstruating/fertile, are pregnant, seeking to become pregnant or lactating. If undergoing menopause, are not stable on medication (no adverse symptoms) for at least the last 3 months
- Have learning and/or behavioural difficulties such as dyslexia or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoker
- excessive caffeine intake (>500 mg per day)
- Have relevant food intolerances/ sensitivities
- Have taken antibiotics within the past 4 weeks
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Sleep disorders or are taking sleep aid medication
- Any known active infections
- Does not have a bank account (required for payment)
- Does not have access to the Internet (inc via smart phone)
- Are non-compliant with regards treatment consumption
Sites / Locations
- Northumbria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
300mg Avena sativa
600mg Avena sativa
900mg Avena sativa
Arm Description
Maltodextrin powder is the placebo ingredient and this is encased in the same pale green capsules as the active ingredient. Participants, if in the placebo group, will consume x3 capsules of placebo per day for 28 days.
If in the 300mg of Avena sativa group, participants will consume x2 placebo capsules (described above) and x1 300mg capsule of Avena sativa per day for 28 days.
If in the 600mg of Avena sativa group, participants will consume x1 placebo capsule (described above) and x2 300mg capsule of Avena sativa per day for 28 days.
If in the 300mg of Avena sativa group, participants will consume x3 300mg capsule of Avena sativa per day for 28 days.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03689348
First Posted
September 27, 2018
Last Updated
March 16, 2020
Sponsor
Northumbria University
Collaborators
Anklam Extrakt
1. Study Identification
Unique Protocol Identification Number
NCT03689348
Brief Title
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
Official Title
Acute and Chronic (28 Days) Effects of Avena Sativa Extract on Physiological and Psychological Responses to Stress, and Mood and Cognitive Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University
Collaborators
Anklam Extrakt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The flavanoid and terpene phytochemicals present in wild green oat interact with multiple mechanisms relevant to brain function; including those which would modulate cognition and stress. The current study aims to test this in a group of N=128 males and females between the ages of 35-65yrs before and after 28 days supplementation of placebo, 300-, 600- and 900mg of a wild green oat extract.
Detailed Description
The flavanoid and terpene phytochemicals present in wild green oat interact with multiple mechanisms relevant to brain function; including those which would modulate cognition and stress. The current study aims to test this in a group of N=128 males and females between the ages of 35-65yrs before and after 28 days supplementation of placebo, 300-, 600- and 900mg of a wild green oat extract. The study is randomized (within x3 age categories also; 35-45, 46-55, 56-65yrs), placebo controlled and counterballanced across parallel groups. Participants will first attend a training/screening session followed by x2 lab-based testing sessions, 28 days apart. In the lab-based sessions participants will complete baseline cognitive assessments; including whilst undergoing a stressful observed methodology (the observed multi-tasking stressor or 'OMS'). Here galvanic skin response and heart rate will be measured and before and after the OMS participants will provide a saliva sample which will be analysed for cortisol and alpha-amylase levels. This procedure will be repeated 120- and 240- minutes post-dose. Between the lab-based sessions participants will complete mood scales via a mobile phone application 'cognimapp'.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Stress, Psychological, Mood
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin powder is the placebo ingredient and this is encased in the same pale green capsules as the active ingredient. Participants, if in the placebo group, will consume x3 capsules of placebo per day for 28 days.
Arm Title
300mg Avena sativa
Arm Type
Experimental
Arm Description
If in the 300mg of Avena sativa group, participants will consume x2 placebo capsules (described above) and x1 300mg capsule of Avena sativa per day for 28 days.
Arm Title
600mg Avena sativa
Arm Type
Experimental
Arm Description
If in the 600mg of Avena sativa group, participants will consume x1 placebo capsule (described above) and x2 300mg capsule of Avena sativa per day for 28 days.
Arm Title
900mg Avena sativa
Arm Type
Experimental
Arm Description
If in the 300mg of Avena sativa group, participants will consume x3 300mg capsule of Avena sativa per day for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Avena sativa
Other Intervention Name(s)
Wild green oat
Intervention Description
A supplement derived from wild green oat
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Changes in mood; as assessed by the 'Profile Of Mood States' (POMS)
Description
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.
Time Frame
Pre-dose and post-dose on day 1 and day 29
Title
Changes in mood; as assessed by the 'General Anxiety Disorder- 7' (GAD-7) questionnaire
Description
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.
Time Frame
Day 1, 8, 15, 22 and 29
Title
Changes in mood; as assessed by the 'General Health Questionnaire' (GHQ)
Description
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.
Time Frame
Pre-dose and post-dose on day 1 and day 29
Title
Changes in cognitive function
Description
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.
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in subjective stress; as assessed by the 'perceived stress scale' (PSS)
Description
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.
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)
Description
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.
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in objective stress; as assessed by salivary cortisol levels
Description
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
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in objective stress; as assessed by salivary alpha-amylase levels
Description
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
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in objective stress; as assessed by galvanic skin response (GSR)
Description
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
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
Title
Changes in objective stress; as assessed by heart rate (HR)
Description
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.
Time Frame
Pre-dose and 120 minutes and 240 minutes post-dose on day 1 and day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must self-assess themselves as being in good health
Aged 35 to 65 years at the time of giving consent
In employment and/or higher education or full time child-care
Exclusion Criteria:
Participants are not eligible to take part if they:
Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progess to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to impede the participant's ability to perform the study assessments, participants may be able to progress to screening.
Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
If still menstruating/fertile, are pregnant, seeking to become pregnant or lactating. If undergoing menopause, are not stable on medication (no adverse symptoms) for at least the last 3 months
Have learning and/or behavioural difficulties such as dyslexia or ADHD
Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
Smoker
excessive caffeine intake (>500 mg per day)
Have relevant food intolerances/ sensitivities
Have taken antibiotics within the past 4 weeks
Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
Are unable to complete all of the study assessments
Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
Suffers from frequent migraines that require medication (more than or equal to 1 per month)
Sleep disorders or are taking sleep aid medication
Any known active infections
Does not have a bank account (required for payment)
Does not have access to the Internet (inc via smart phone)
Are non-compliant with regards treatment consumption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Wightman, Dr
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 8ST
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will be shared with the study sponsor (Anklam Extrakt) and the named investigators.
Learn more about this trial
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
We'll reach out to this number within 24 hrs