Cognitive Effects of Sage in Healthy Humans
关键词
抽象
描述
Improved cognitive performance has been observed in humans following supplementation of sage extracts; including recall and mental arithmetic ability. Aspects of mood have also shown improvements; e.g. increased alertness, calmness and contentedness and reduced mental fatigue. These effects are believed to be underpinned by interactions with cholinergic and GABA pathways. Polyphenols too have shown promise in boosting cognition and mood and interaction with vasodilatory pathways and GABA neurotransmission are purported to be the likely mechanisms involved. Research has yet to investigate if a combination of sage terpenes and polyphenols could be even more efficacious via synergistic interaction.The current study investigates the effects of a 600 mg sage/polyphenol combination on cognition and mood in N=90 healthy male and female participants between the ages of 30-60 yrs acutely; on day 1 of supplementation, and chronically; after 29 days. Cognitive and mood data will also be collected every 7 days in the interim via a mobile phone cognitive task battery.
日期
| 最后验证: | 02/29/2020 |
| 首次提交: | 09/19/2018 |
| 提交的预估入学人数: | 10/01/2018 |
| 首次发布: | 10/02/2018 |
| 上次提交的更新: | 03/15/2020 |
| 最近更新发布: | 03/16/2020 |
| 实际学习开始日期: | 09/02/2018 |
| 预计主要完成日期: | 09/23/2019 |
| 预计完成日期: | 09/23/2019 |
状况或疾病
干预/治疗
Dietary Supplement: 600 mg sage/polyphenol combination
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 600 mg sage/polyphenol combination 600 mg of this sage/polyphenol combination will be consumed, via capsule, per day for 29 days. | Dietary Supplement: 600 mg sage/polyphenol combination Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira |
| Placebo Comparator: Placebo The same number of aesthetically similar capsules will be consumed per day for 29 days. | Dietary Supplement: Placebo Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules |
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Participants must self-assess themselves as being in good health. - Aged 30 to 60 years at the time of giving consent - In daytime employment and/or higher education Exclusion Criteria: - 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 progress 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, 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 18.5-30 kg/m2 - Are pregnant, seeking to become pregnant or lactating - 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 food intolerances/ sensitivities - Have taken antibiotics, prebiotics or probiotics (including drinks. Eg. Yakult or Actimel) within the past 8 weeks - Have any health condition that would prevent fulfillment 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 disturbances (including night-shift work) and/ or are taking sleep aid medication - Any known active infections - Does not have a bank account (required for payment) - Are non-compliant with regards treatment consumption (see 4.3) |
结果
主要结果指标
1. Acute change in global cognitive task performance [120 minutes and 240 minutes post dose on day 1 of treatment supplementation]
2. Acute changes in mood; as assessed by the Bond-Lader mood scales [120 minutes and 240 minutes post dose on day 1 of treatment supplementation]
3. Interim changes in global cognitive task performance [Day 7, day 14, day 21 and day 28]
4. Chronic changes in cognitive task performance [Pre-dose, 120 minutes and 240 minutes post-dose on day 29 of treatment supplementation]
5. Chronic changes in mood; as assessed by the Bond-Lader mood scales [Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation]
6. Change in prospective memory performance; as assessed by a prospective memory task (the prospective remembering video task) [Day 25 and day 29]
7. Acute changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI) [120 minutes and 240 minutes post dose on day 29 of treatment supplementation]
8. Chronic changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI) [120 minutes and 240 minutes post dose on day 29 of treatment supplementation]
次要成果指标
1. Acute changes in blood pressure [120 minutes and 240 minutes post dose on day 1 of treatment supplementation]
2. Chronic changes in blood pressure [Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation]
3. Acute changes in heart rate [120 minutes and 240 minutes post dose on day 1 of treatment supplementation]
4. Chronic changes in heart rate [Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation]
