Effects of a supplement combination on stress and sleep in healthy adults
Evaluating the Efficacy of a Supplement Combination for Improving Stress and Sleep: A Randomized Placebo-Controlled Clinical Trial
This study tests whether a mix of supplements can help healthy adults aged 18 to 50 sleep better and feel less stressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of South Carolina Academic / other |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT06889584 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates how a combination of supplements affects sleep quality and stress levels in healthy adults aged 18 to 50. Participants will receive various active supplement combinations, including Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin, or placebos. The study aims to determine the efficacy of these supplements in improving sleep and reducing stress through a structured intervention. Participants will be monitored for their responses to the supplements over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 50 with a BMI between 18.5 and 29.9 who are physically active.
Not a fit: Patients with known allergies to any of the investigational products or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural approach to improving sleep quality and reducing stress for healthy adults.
How similar studies have performed: While there have been studies on individual supplements for stress and sleep, this specific combination approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Columbia, South Carolina
- University of South Carolina Sport Science Lab — Columbia, South Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.