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Mood (Psychological Function)NCT02734251

Effect of Relora Supplement on Anxiety, Cognitive Performance & Mood Tested After Induced Stress

A study testing Relora in people with Mood (Psychological Function), run by InterHealth Nutraceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Mood (Psychological Function)
What is being tested?
Relora
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
Feb 2016to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MB Clinical Research

    Boca Raton, Florida, 33487

Other trials in United States

About this study

Official title: 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.

Being tested
Relora, Placebo
Keywords
Healthy mood, Stress management, Relora, Healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReloraDietary supplement

    750 mg/day

  • PlaceboDietary supplement

Study groups in NCT02734251
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDietary Supplement: Placebo
Receives: Dietary Supplement: Placebo
ReloraExperimentalDietary Supplement: Relora, 750 mg/day
Receives: Dietary Supplement: Relora

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 7

Secondary outcomes (3)

  1. 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

    Measured: Day 7

  2. 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.

    Measured: Day 7

  3. 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.

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734251
Sponsor's protocol ID
MC-1514
Status last verified
May 2016
First submitted
5 Apr 2016
Last updated
24 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Relora in people with Mood (Psychological Function), run by InterHealth Nutraceuticals, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.

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