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| Name | Class |
|---|---|
| MB Clinical Research, LLC | UNKNOWN |
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The present randomized, double-blind, placebo-controlled crossover trial aims to evaluate the effects of Relora supplementation on responses to induced stress produced by a combination of cognitive and physiologic stressors in healthy men and women. The effects of the supplement, compared with a placebo, will be evaluated using measures to assess anxiety [State-Trait Anxiety Inventory-Part 1 (STAI-Part 1), mood [Bond-Lader Visual Analog Scale (VAS)], hypothalamic-pituitary-adrenal axis activation (salivary cortisol) and cognitive function (cognitive flexibility, reaction time, processing speed, attention, sustained attention, working memory, and executive function). Testing will be completed at the beginning and end of 7-d supplementation periods with the active and placebo products to assess both the acute effects and the "acute-on-chronic" effects following one week of daily use.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dietary Supplement: Placebo |
|
| Relora | Experimental | Dietary Supplement: Relora, 750 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relora | Dietary Supplement | 750 mg/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean STAI-Part 1 post-dose score (collected as part of the test battery at the t = 90 and 180 min timepoints) at the end (day 7) of each of the two treatment conditions. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Total area under the curve (AUC) for salivary cortisol from 90 to 150 min and 180 to 240 min at the end (day 7) of each of the two treatment conditions | Day 7 | |
| Bond-Lader post-dose VAS scores (collected as part of the test battery at the t = 90 and 180 min timepoints) at the end (day 7) of each of the two treatment conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| STAI-Part 1 mean and individual timepoint post-dose scores (collected as part of the test battery at the t = 90 and 180 min timepoints) at the start (day 1) of each of the two treatment conditions. | Day 1 | |
| Total area under the curve (AUC) for salivary cortisol from 90 to 150 min and 180 to 240 min at the start (day 1) of each of the two treatment conditions. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth J Baum, MD | MB Clinical Research | Principal Investigator |
| Kevin C Maki, PhD | MB Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MB Clinical Research | Boca Raton | Florida | 33487 | United States |
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| Dietary Supplement |
|
| Day 7 |
| Cognitive function post-dose test scores (collected as part of the test battery at the t = 90 and 180 min timepoints) at the end (day 7) of each of the two treatment conditions. | Day 7 |
| Day 1 |
| Bond-Lader post-dose VAS scores (collected as part of the test battery at the t = 90 and 180 min timepoints) at the start (day 1) of each of the two treatment conditions. | Day 1 |
| Cognitive function post-dose test scores (collected as part of the test battery at the t = 90 and 180 min timepoints) at the start (day 1) of each of the two treatment conditions | Day 1 |
| Safety will be assessed by vital signs measured at the beginning and end of the study, as well as AEs reported by subjects at each post-randomization clinic visit. | Entire study period |
| Exploratory analyses will be completed to assess possible predictors of response. | Day 1 and Day 7 |