Supplement Combination on Stress and Sleep

Last updated: March 16, 2025
Sponsor: University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)

AM and PM Placebo

Clinical Study ID

NCT06889584
Pro00141237
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy participants aged 18 to 50 years (inclusive) at the time of screening with abody mass index of 18.5 to 29.9 kg/m2.

  • Willing to give voluntary consent, be able to understand and read thequestionnaires, carry out all study-related procedures, communicate effectively withthe study staff, and agree to allow any study-related evaluations.

  • Participant is physically active: participating in resistance and/or enduranceexercise ≥150 min/wk for ≥6 mo.

  • Participant will be asked about dietary supplementation use within the past 6months.

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

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 pregnantduring 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 1hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89mmHg).

  • Any other condition or abnormality that, in the opinion of the investigator, wouldcompromise the safety of the participant or the quality of the study data.

Study Design

Total Participants: 115
Treatment Group(s): 4
Primary Treatment: All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin))
Phase:
Study Start date:
February 15, 2025
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • University of South Carolina Sport Science Lab

    Columbia, South Carolina 29208
    United States

    Active - Recruiting

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