University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208, United States
NCT Number: NCT06889584
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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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Columbia, South Carolina, 29208, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.
Ashwagandha and Rhodiola rosea
Magnesium threonate, L-theanine, and apigenin.
Placebo AM and PM
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Daily for 4-weeks from baseline to Day 28.
Assessed by the Absolute Rest device, higher scores are better.
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.
Time frame: Daily for 4-weeks from baseline to Day 28.
Assessed by the Absolute Rest device, time taken to fall asleep.
Time frame: Daily for 4-weeks from baseline to Day 28.
Assessed by the Absolute Rest device, total sleep time.
Time frame: Daily for 4-weeks from baseline to Day 28.
Assessed by the Absolute Rest device, values measures by oxygen saturation.
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.
University of South Carolina
Other
Evaluating the Efficacy of a Supplement Combination for Improving Stress and Sleep: A Randomized Placebo-Controlled Clinical Trial
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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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