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

NCT06672965 | Completed

• 1 other identifier: RIGCLI22M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Evaluations, Diagnostic Self

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Assessment of mood using Profile of Mood States (POMS) scale

  30 days

• Assessment of sleep using Restorative Sleep Questionnaire, Weekly (RSQ-W) version scale

  30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Calming supplement

ACTIVE COMPARATOR

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

Interventions

anti-stress supplement DIETARY_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.

Calming supplement

Placebo DIETARY_SUPPLEMENT

Subjects were given 60 capsules of placebo (30-day supply) and instructed to take two capsules each day orally with water.

Placebo

Eligibility Criteria

• Age: 40 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
• Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.
• Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
• Having taken anti-depressants/anti-anxiety/mood enhancing/ recreational drugs (e.g., marijuana) within 6 months prior to screening.
• Having smoked, vaped, or used recreational drugs (e.g., marijuana, THC, CBD) within the last 6 months prior to screening.
• Having any known chronic skin conditions that may be exacerbated with using a topical product.
• Pregnant, planning to become pregnant or nursing.
• Any known allergy or intolerance to any of the ingredients contained in supplements or topical product.
• 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.
• Any disease or condition of the skin that the examining investigator deems inappropriate for participation, including rosacea, eczema, and atopic dermatitis.
• 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.
• 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.
• Individuals who have used Retinol in the last six months.
• Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site.
• Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical.

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

PCR Corp

Manchester, M13 0AF, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 4, 2024
• Study Start: June 19, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 30, 2023
• Last Updated: November 4, 2024

Record last verified: 2024-09

Locations

GB (1)