Supplement Combination on Stress and Sleep

February 8, 2026 updated by: Shawn M. Arent, University of South Carolina

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina Sport Science Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AM active, PM active
Combination product: All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin))
Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.
Active Comparator: AM active, PM placebo
Combination product: AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)
Ashwagandha and Rhodiola rosea
Active Comparator: AM placebo, PM active
Combination product: PM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin)
Magnesium threonate, L-theanine, and apigenin.
Placebo Comparator: AM placebo, PM placebo
Other: AM and PM Placebo
Placebo AM and PM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 7, Day 14, Day 21, Day 28
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.
Baseline, Day 7, Day 14, Day 21, Day 28
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.
Baseline, Day 7, Day 14, Day 21, Day 28
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.
Baseline, Day 7, Day 14, Day 21, Day 28
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.
Baseline, Day 7, Day 14, Day 21, Day 28
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.
Daily for 4-weeks from baseline to Day 28.
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.
Daily for 4-weeks from baseline to Day 28.
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.
Baseline and Day 28.
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.
Daily for 4-weeks from baseline to Day 28.
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.
Daily for 4-weeks from baseline to Day 28.
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.
Daily for 4-weeks from baseline to Day 28.
Changes in sleep duration
Time Frame: Daily for 4-weeks from baseline to Day 28.
Assessed by the Absolute Rest device, total sleep time.
Daily for 4-weeks from baseline to Day 28.
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.
Daily for 4-weeks from baseline to Day 28.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
End of Week 2 and Week 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Momentous

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00141237

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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