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Completed

NCT Number: NCT06889584

Supplement Combination on Stress and Sleep

The purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy participants aged 18 to 50 years (inclusive) at the time of screening with a body mass index of 18.5 to 29.9 kg/m2.
  • Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study-related evaluations.
  • Participant is physically active: participating in resistance and/or endurance exercise ≥150 min/wk for ≥6 mo.
  • Participant will be asked about dietary supplementation use within the past 6 months.

If participant began taking a supplement within the past month, participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.In all other cases, supplement use will be asked to be maintained throughout the study.

  • The participant has an apple device with iOS 16 or greater software.

Exclusion criteria

  • Have a known sensitivity of allergy to any of the investigational products.
  • Participants currently taking any of the investigational products will be excluded.
  • Female participants who are lactating, pregnant, or planning to become pregnant during the study.
  • Diagnosed with any sleep-related or stress-related disorders.
  • Currently taking medication to manage sleep or cortisol levels.
  • Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
  • Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.

Treatment and study plan

All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin))

Combination Product

Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.

AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)

Combination Product

Ashwagandha and Rhodiola rosea

PM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin)

Combination Product

Magnesium threonate, L-theanine, and apigenin.

AM and PM Placebo

Other

Placebo AM and PM

Primary outcomes

  1. Cohen's Perceived Stress scale

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    To determine changes in perceived stress by way of the Cohen's Perceived Stress scale. The minimum is 0 and max is 40, with higher values meaning more stress.

  2. Positive mood and emotion

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    Assessed by the Positive and Negative Affect Scale. Min values of 0 and max of 50, higher scores indicate more positive moods and emotions.

  3. Negative mood and emotion

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    Assessed by the Positive and Negative Affect Schedule. Min values of 0 and max of 50, higher scores indicate more negative moods and emotions.

  4. Weekly sleep disturbances.

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    Assessed by the Patient Reported Outcome Measures of sleep disturbances. Min values of 8 and max values of 40. Higher scores mean more sleep disturbances.

  5. Weekly sleep impairment

    Time frame: Baseline, Day 7, Day 14, Day 21, Day 28

    Assessed by the Patient Reported Outcome Measures of sleep impairments. Min values of 8 and max values of 40. Higher scores mean more sleep impairments.

  6. Changes in daily psychological stress

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Daily Stress Response Scale. Min 0, max 60 with higher scores indicating higher stress.

  7. Changes in daily physiological stress

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by Daily Stress Response Scale. Min 0, max 60 with higher scores indicating higher stress.

  8. Changes in subjective sleep quality.

    Time frame: Baseline and Day 28.

    Assessed by the Pittsburgh Sleep Quality Index questionnaire. Min 0 and max 21, higher scores indicate worse sleep quality.

  9. Changes in objective sleep quality.

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Absolute Rest device, higher scores are better.

  10. Changes in sleep efficiency.

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Absolute Rest device, total time asleep divided by time in bed, expressed as a percentage, higher is better.

  11. Changes in sleep latency

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Absolute Rest device, time taken to fall asleep.

  12. Changes in sleep duration

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Absolute Rest device, total sleep time.

  13. Changes in sleep apnea

    Time frame: Daily for 4-weeks from baseline to Day 28.

    Assessed by the Absolute Rest device, values measures by oxygen saturation.

Secondary outcomes

  1. Percent compliance of supplement use

    Time frame: End of Week 2 and Week 3.

    To determine the percent of compliance when taking AM and PM pills. Will be measured by the amount of pills taken / pills prescribed multiplied by 100.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Momentous

Registry information

Official study title

Evaluating the Efficacy of a Supplement Combination for Improving Stress and Sleep: A Randomized Placebo-Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Feb 11, 2026

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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