Supplement Combination on Stress and Sleep

NCT ID: NCT06889584

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled, between subjects, double-blind.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AM active, PM active

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.

AM active, PM placebo

Group Type ACTIVE_COMPARATOR

AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)

Intervention Type COMBINATION_PRODUCT

Ashwagandha and Rhodiola rosea

AM placebo, PM active

Group Type ACTIVE_COMPARATOR

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

Intervention Type COMBINATION_PRODUCT

Magnesium threonate, L-theanine, and apigenin.

AM placebo, PM placebo

Group Type PLACEBO_COMPARATOR

AM and PM Placebo

Intervention Type OTHER

Placebo AM and PM

Interventions

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

Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin.

Intervention Type COMBINATION_PRODUCT

AM Active Supplement Combination (Ashwagandha and Rhodiola rosea)

Ashwagandha and Rhodiola rosea

Intervention Type COMBINATION_PRODUCT

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

Magnesium threonate, L-theanine, and apigenin.

Intervention Type COMBINATION_PRODUCT

AM and PM Placebo

Placebo AM and PM

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Momentous

UNKNOWN

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Shawn M. Arent

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of South Carolina Sport Science Lab

Columbia, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00141237

Identifier Type: -

Identifier Source: org_study_id

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