Clinical trial NCT06889584: Supplement Combination on Stress and Sleep
Official title: Evaluating the Efficacy of a Supplement Combination for Improving Stress and Sleep: A Randomized Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Sleep
Stress
Supplement
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Momentous
First posted: 2025-03-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, between subjects, double-blind.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cohen's Perceived Stress scale
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: Positive mood and emotion
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: Negative mood and emotion
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: Weekly sleep disturbances.
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: Weekly sleep impairment
timeFrame: Baseline, Day 7, Day 14, Day 21, Day 28
measure: Changes in daily psychological stress
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in daily physiological stress
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in subjective sleep quality.
timeFrame: Baseline and Day 28.
measure: Changes in objective sleep quality.
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in sleep efficiency.
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in sleep latency
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in sleep duration
timeFrame: Daily for 4-weeks from baseline to Day 28.
measure: Changes in sleep apnea
timeFrame: Daily for 4-weeks from baseline to Day 28.
Secondary outcomes:
measure: Percent compliance of supplement use
timeFrame: End of Week 2 and Week 3.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: