- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02734251
Effect of Relora Supplement on Anxiety, Cognitive Performance & Mood Tested After Induced Stress
May 20, 2016 updated by: InterHealth Nutraceuticals, Inc.
Effects of Magnolia and Phellodendron (Magnolia Officinalis and Phellodendron Amurense) Bark Extracts on Anxiety, Cognitive Performance, and Mood Tested After Induced Stress
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33487
- MB Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is a male or female, 21-59 years of age, inclusive.
- Subject is judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
- Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at visit 1 (day -6).
- Subject is a non-user of nicotine products for 6 months prior to visit 1 (day -6).
- Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period.
- Subject is willing and able to attend the screening visit and 4 test visits lasting up to ~4 h each (visits 2 through 5; days 1 and 7 of Period I and Period II, respectively).
- Subject is able to maintain immersion of non-dominant hand, including the forearm, into ice water (0-4°C) for ≥30 seconds during the CPT at visit 1 (day -6).
- Subject is willing to refrain from alcohol for 12 h prior to each test visit (visits 2 through 5; days 1 and 7 of Periods I and II, respectively) and to limit alcohol consumption to no more than one serving of alcohol (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) the 24 h prior to each test visit (visits 2, 3, 4, and 5; days 1 and 7 of Period I and Period II, respectively).
- Subject is willing to limit caffeine-containing beverages/foods/products consumed at the breakfast meal on all test visit days (visits 2, 3, 4, and 5; days 1 and 7 of Period I and Period II, respectively) to no more than 1 serving (150 mg) ≥2 h prior to each test visit.
- Subject is willing to consume a hearty breakfast on a daily basis throughout the study period with replication of the timing and quantities of food and beverages consumed at the visit 2 (day 1) breakfast meal on the morning of each subsequent test visit (visits 3 through 5; day 7 of Period I and days 1 and 7 of Period II).
- Subject is willing to replicate the timing and dose of any necessary morning medications and/or supplements taken prior to coming to clinic on visit 2 (day 1) at each subsequent test visit (visits 3 through 5; day 7 of Period I and days 1 and 7 of Period II).
- Subject is willing and able to comfortably abstain from caffeine throughout the duration of all test visits (~5 h; visits 2, 3, 4, and 5; days 1 and 7 of Period I and Period II, respectively).
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Exclusion Criteria:
- Subject has a history or presence of clinically important cardiac, renal, hepatic, endocrine (including Type 1 and Type 2 diabetes mellitus), pulmonary, biliary, pancreatic, or neurologic disorders.
- Subject has a history of diagnosed generalized anxiety, and/or other major psychiatric disorder(s), other than diagnosed depression.
- Subject has a history of diagnosed depression in the 2 years prior to visit 1 (day -6) and/or a score of 17 or higher on the Beck Depression Scale.
- Subject has an abnormal comprehensive metabolic panel and/or complete blood count test result of clinical significance. A reflex HbA1C may be assessed on subjects with a blood glucose ≥126 mg/dL to determine glycemic status, at discretion of Investigator.
- Subject tests positive for any of the substances included in urine drug screen (i.e., cocaine, tetrahyrdocannabinol, opiates, amphetamines, methamphetamines, phencyclidines, benzodiazepines, barbiturates, methadone, oxycodone, methylenedioxymethamphetamine, and propoxyphene).
- Subject is unable to understand and/or perform required tests based on the practice test results.
- Subject has a history of unconventional sleep patterns (e.g., night shift), a diagnosed sleep disorder, or a chronic medical condition that may impact mood and/or cognition levels, in the judgment of the Investigator.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at visit 1 (day -6).
- Subject has an active infection or signs/symptoms of an infection. Test visits will be re-scheduled to allow subject to be symptom-free from any type of systemic infection for at least 5 d.
- Subject has a known allergy or sensitivity to any ingredients in the study products.
- Subject has used recreational drugs or prescription medications with potential to influence mood, anxiety, cognitive function, and/or modulate the autonomic nervous system (including narcotic (opioid) pain medications) within 4 weeks of visit 1 (day -6).
- Subject has used nicotine withdrawal/replacement therapy within 6 months of visit 1 (day -6).
- Subject has used over-the-counter medications, supplements, and/or products, which may influence mood, anxiety, and/or cognitive function within 2 weeks of visit 1 (day -6).
- Subject has a history of cancer within 5 years prior to visit 1 (day -6), except for non-melanoma skin cancer.
- Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Subject has a current or recent history (past 12 months of visit 1, day -6) or strong potential for drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Subject has been exposed to any non-registered drug product within 30 d prior to visit 1 (day -6).
- Individual has a condition the Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results, or put the subject at undue risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Dietary Supplement: Placebo
|
|
Experimental: Relora
Dietary Supplement: Relora, 750 mg/day
|
750 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Day 7
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Day 7
|
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.
Time Frame: Day 7
|
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.
Time Frame: Day 7
|
Day 7
|
Other Outcome Measures
Outcome Measure |
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.
Time Frame: Day 1
|
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.
Time Frame: Day 1
|
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.
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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.
Time Frame: Entire study period
|
Entire study period
|
Exploratory analyses will be completed to assess possible predictors of response.
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Seth J Baum, MD, MB Clinical Research
- Study Director: Kevin C Maki, PhD, MB Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
April 5, 2016
First Submitted That Met QC Criteria
April 5, 2016
First Posted (Estimate)
April 12, 2016
Study Record Updates
Last Update Posted (Estimate)
May 24, 2016
Last Update Submitted That Met QC Criteria
May 20, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- MC-1514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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