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

Inclusion Criteria:

1. Subject is a male or female, 21-59 years of age, inclusive.

2. Subject is judged by the Investigator to be in general good health on the basis of
medical history and screening laboratory tests.

3. Subject has a BMI of 18.50-29.99 kg/m2, inclusive, at visit 1 (day -6).

4. Subject is a non-user of nicotine products for 6 months prior to visit 1 (day -6).

5. Subject is willing to maintain a habitual diet and physical activity patterns
throughout the study period.

6. 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).

7. 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).

8. 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).

9. 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.

10. 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).

11. 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).

12. 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).

13. 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:

1. 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.

2. Subject has a history of diagnosed generalized anxiety, and/or other major
psychiatric disorder(s), other than diagnosed depression.

3. 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.

4. 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.

5. 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).

6. Subject is unable to understand and/or perform required tests based on the practice
test results.

7. 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.

8. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or
diastolic blood pressure ≥100 mm Hg) at visit 1 (day -6).

9. 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.

10. Subject has a known allergy or sensitivity to any ingredients in the study products.

11. 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).

12. Subject has used nicotine withdrawal/replacement therapy within 6 months of visit 1
(day -6).

13. 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).

14. Subject has a history of cancer within 5 years prior to visit 1 (day -6), except for
non-melanoma skin cancer.

15. 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.

16. 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).

17. Subject has been exposed to any non-registered drug product within 30 d prior to
visit 1 (day -6).

18. 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.