Supplement Combination on Stress and Sleep

NCT06889584 | Completed

• 1 other identifier: Pro00141237
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Sleep; Stress; Supplement

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Percent compliance of supplement use

  End of Week 2 and Week 3.

Study Arms (4)

AM active, PM active

EXPERIMENTAL

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

AM active, PM placebo

ACTIVE COMPARATOR

Combination Product: AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)

AM placebo, PM active

ACTIVE COMPARATOR

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

AM placebo, PM placebo

PLACEBO COMPARATOR

Other: AM and PM Placebo

Interventions

AM Active Supplement Combination (Ashwagandha and Rhodiola rosea) COMBINATION_PRODUCT

Ashwagandha and Rhodiola rosea

AM active, PM placebo

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

Magnesium threonate, L-theanine, and apigenin.

AM placebo, PM active

AM and PM Placebo OTHER

Placebo AM and PM

AM placebo, PM placebo

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, PM active

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead
• Momentous: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Interventions

Ashwagandha; threonic acid; theanine; Apigenin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, placebo-controlled, between subjects, double-blind.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 21, 2025
• Study Start: February 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (1)