Healthy
Conditions
Keywords
Sleep, Stress, Supplement
Brief summary
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.
Interventions
COMBINATION_PRODUCTAll Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin))
Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.
COMBINATION_PRODUCTAM Active Supplement Combination (Ashwagandha and Rhodiola rosea)
Ashwagandha and Rhodiola rosea
COMBINATION_PRODUCTPM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin)
Magnesium threonate, L-theanine, and apigenin.
OTHERAM and PM Placebo
Placebo AM and PM
Sponsors
University of South Carolina
Momentous
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, placebo-controlled, between subjects, double-blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sleep latency | Daily for 4-weeks from baseline to Day 28. | Assessed by the Absolute Rest device, time taken to fall asleep. |
| Changes in sleep duration | Daily for 4-weeks from baseline to Day 28. | Assessed by the Absolute Rest device, total sleep time. |
| Changes in sleep apnea | Daily for 4-weeks from baseline to Day 28. | Assessed by the Absolute Rest device, values measures by oxygen saturation. |
| Changes in sleep efficiency. | 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. |
| Cohen's Perceived Stress scale | 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. |
| Positive mood and emotion | 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. |
| Negative mood and emotion | 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. |
| Weekly sleep disturbances. | 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. |
| Weekly sleep impairment | 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. |
| Changes in daily psychological stress | 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. |
| Changes in daily physiological stress | 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. |
| Changes in subjective sleep quality. | Baseline and Day 28. | Assessed by the Pittsburgh Sleep Quality Index questionnaire. Min 0 and max 21, higher scores indicate worse sleep quality. |
| Changes in objective sleep quality. | Daily for 4-weeks from baseline to Day 28. | Assessed by the Absolute Rest device, higher scores are better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent compliance of supplement use | 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. |
Countries
United States
Outcome results
None listed