A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placebo in Subjects with Mild to Moderate Levels of Stress

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

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 Overview

• Status: Completed
• Conditions: Evaluations, Diagnostic Self
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: anti-stress supplement

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 0AF
    • PCR Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo was prepared as a capsule composed of excipients only (stearic acid and natural caramel color to match the mg weight of the combination supplement capsule). Take two (2) capsules daily with water.	Dietary supplement: Placebo; Subjects were given 60 capsules of placebo (30-day supply) and instructed to take two capsules each day orally with water.
Active Comparator: Calming supplement; The combination supplement was prepared to deliver 600 mg of Lemon Balm extract, 100 mg of Magnolia Bark extract (containing 40 mg of honokiol) and 200 mg L-theanine daily in 2 capsules with water.	Dietary supplement: anti-stress supplement; The anti-stress supplement was developed to provide relief from anxiety and depression levels.Subjects were given 60 capsules of calming supplement (30-day supply) and instructed to take two capsules each day orally with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale	Hamilton Anxiety Rating Scale (HAM-A) (1) was assessed using a questionnaire and scored on a scale of 0 to 4, with 0 (no presence of anxiety) to 4 (severe anxiety). (1) Hamilton, M. The assessment of anxiety states by rating. Br. J. Med. Psychol. 1959, 32, 50-55.	30 days
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale	Hamilton Depression Rating Scale (HDRS) (1) was assessed using a questionnaire and scored using a scale of 0 to 20, with 0-7 (within normal range or remission) while a score of 20 (indicating moderate depression. (1) Hamilton, M. A rating scale of depression. J. Neurol. Neurosurg. Psychiatry, 1960, 23, 56-62.	30 days
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)	Perceived stress was assessed with Perceived Stress Scale (PSS) using a validated questionnaire on a score of 0 to 40, with 0 (no stress) and 20 or above (higher perceived stress) at day 1, day 7 and at day 30.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of mood using Profile of Mood States (POMS) scale	Assessment of Profile of Mood States (POMS) was measured on a 5 point scale of 0 to 5, with 0 (not at all moody) to 4 (extremely moody),	30 days
Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale	Restorative Sleep Questionnaire, Weekly (RSQ-W) is a nine-item survey that measures how restful a person feels after sleeping for the past week. The RSQ-W scale scores range from 0-100, with higher scores indicating more restorative sleep. To convert the average score to a 0-100 scale, use the formula: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1.0}*25.	30 days

Collaborators and Investigators

• Sponsor: Pharmanex

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RIGCLI22M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No