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Completed

NCT Number: 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

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

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Key information

Age range

40 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PCR Corp

Manchester, M13 0AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Individuals taking high dose biotin (i.e., >5 mg / > 5000 μg per day).
  • Individuals who work night shifts.

Treatment and study plan

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.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale

    Time frame: 30 days

    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.

  2. Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale

    Time frame: 30 days

    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.

  3. Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)

    Time frame: 30 days

    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.

Secondary outcomes

  1. Assessment of mood using Profile of Mood States (POMS) scale

    Time frame: 30 days

    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),

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

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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