Supplement Combination on Stress and Sleep

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Combination product: All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin)); Combination product: AM Active Supplement Combination (Ashwagandha and Rhodiola rosea); Combination product: PM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin); Other: AM and PM Placebo

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cohen's Perceived Stress scale	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	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	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.	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	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	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	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.	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.	Assessed by the Absolute Rest device, higher scores are better.	Daily for 4-weeks from baseline to Day 28.
Changes in sleep efficiency.	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	Assessed by the Absolute Rest device, time taken to fall asleep.	Daily for 4-weeks from baseline to Day 28.
Changes in sleep duration	Assessed by the Absolute Rest device, total sleep time.	Daily for 4-weeks from baseline to Day 28.
Changes in sleep apnea	Assessed by the Absolute Rest device, values measures by oxygen saturation.	Daily for 4-weeks from baseline to Day 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent compliance of supplement use	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

• Sponsor: University of South Carolina
• Collaborators: Momentous

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Sleep; Supplement
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Benzopyrans; Flavonoids; Chromones; Flavones; Ashwagandha; theanine; threonic acid; Apigenin
• Other Study ID 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