Clinical trial NCT06672965: A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placebo in Subjects with Mild to Moderate Levels of Stress
Official title: A Single Centre, Double Blind, Placebo-controlled Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress in Subjects with Mild to Moderate Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluations, Diagnostic Self
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A single centre, double blind, placebo-controlled clinical study design in healthy subjects to evaluate the efficacy of dietary supplement to alleviate stress in subjects with mild to moderate stress


Eligibility criteria: Inclusion Criteria:

1. Must complete pre-study assessment questionnaire and have a minimum stress level score of ≥14.
2. The subject is a healthy male or female 25-55 years of age at the time of informed consent.
3. The subject must have a BMI of ≥18.5 and ≤30.0 kg/m2 and be willing to have their height and weight measured.
4. No reported history of psychological or mental disorders.
5. Free of anti-depressants/anti-anxiety/mood enhancing/recreational drugs (e.g., marijuana, THC, CBD) intake for at least 6 months prior to screening.
6. Free of any 'over the counter' or prescribed medications except for female participants taking contraceptive pills.
7. Agree to abstain from smoking, vaping, or using recreation drugs (e.g., marijuana, THC, CBD) during the study.
8. Willing and able to give informed consent.

Exclusion Criteria:

1. Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
2. Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.
3. Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
4. Having taken anti-depressants/anti-anxiety/mood enhancing/ recreational drugs (e.g., marijuana) within 6 months prior to screening.
5. Having smoked, vaped, or used recreational drugs (e.g., marijuana, THC, CBD) within the last 6 months prior to screening.
6. Having any known chronic skin conditions that may be exacerbated with using a topical product.
7. Pregnant, planning to become pregnant or nursing.
8. Any known allergy or intolerance to any of the ingredients contained in supplements or topical product.
9. Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results.
10. Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, and atopic dermatitis.
11. Individuals currently taking certain medications which in the opinion of the investigators may interfere with the Study. This would include but not be limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids) immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted), and insulin, antihypertensive drugs, antibiotics, or other topical drugs at the test sites.
12. Individuals who have routinely used an alpha-hydroxy-acid (AHA) or a betahydroxy-acid (BHA) containing product within two weeks or Retin-A®, Retin-A Micro®, Renovar®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of the Study start or have taken Accutane® within one year of the Study start.
13. Individuals who have used Retinol in the last six months.
14. Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site.
15. Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical.
16. Individuals taking high dose biotin (i.e., \>5 mg / \> 5000 μg per day).
17. Individuals who work night shifts.

Primary outcomes:
measure: Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
timeFrame: 30 days
measure: Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
timeFrame: 30 days
measure: Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of mood using Profile of Mood States (POMS) scale
timeFrame: 30 days
measure: Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale
timeFrame: 30 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: PCR Corp
Study officials:
References: