Supplement Combination on Stress and Sleep

University of South Carolina

Status: Enrolling

Conditions: Healthy

Treatments: Other: AM and PM Placebo; Combination Product: PM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin); Combination Product: AM Active Supplement Combination (Ashwagandha and Rhodiola rosea); Combination Product: All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin))

Study type: Interventional

Funder types: Other

Identifiers

NCT06889584

Pro00141237

Details and patient eligibility

About

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.

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 4 patient groups, including a placebo group

AM active, PM active

Experimental group

Treatment:

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

AM active, PM placebo

Active Comparator group

Treatment:

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

AM placebo, PM active

Active Comparator group

Treatment:

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

AM placebo, PM placebo

Placebo Comparator group

Treatment:

Other: AM and PM Placebo