Supplement Combination for Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Sleep medications, Cortisol medications

Disqualifiers: Pregnancy, Sleep disorders, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

115 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking medication to manage sleep or cortisol levels, you cannot participate. If you started a new supplement in the past month, you'll need to stop it and wait for 2 weeks before joining the study.

Is the Supplement Combination generally safe for humans?

There is limited evidence on the safety of dietary supplements, and some can cause significant side effects or interact with medications. Reports have highlighted safety issues with certain herbs, and military personnel using supplements have experienced adverse events, indicating potential risks. ^{1 2 3 4 5}

How does the treatment 'All Active Supplement Combinations' differ from other treatments for improving physical performance and body composition?

The 'All Active Supplement Combinations' treatment is unique because it combines different supplements to potentially enhance physical performance and body composition, as seen in similar studies where mixed nutritional supplements helped maintain body mass and performance during intense training. This approach may offer a synergistic effect by combining various nutrients, unlike single-ingredient supplements. ^{6 7 8 9 10}

What is the purpose of this trial?

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

This trial is for healthy adults interested in exploring how a combination of supplements might affect their sleep quality and stress levels. Specific eligibility criteria are not provided, so it's best to contact the study organizers for details on who can participate.

Inclusion Criteria

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

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Participants currently taking any investigational products

I am on medication for sleep or to manage cortisol levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a supplement combination to assess effects on sleep quality and stress

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• All Active Supplement Combinations
• AM Active Supplement Combination
• PM Active Supplement Combination

Trial Overview The trial is testing different combinations of supplements taken in the morning (Ashwagandha, Rhodiola rosea) and evening (Magnesium threonate, L-theanine, apigenin), as well as all combined versus placebo. The goal is to see if these combinations improve sleep and reduce stress.

Participant Groups

Group I: AM active, PM active Experimental Treatment 1 Intervention

Group II: AM placebo, PM active Active Control 1 Intervention

Group III: AM active, PM placebo Active Control 1 Intervention

Group IV: AM placebo, PM placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Momentous

Collaborator

Trials

1

Recruited

120+

Findings from Research

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Over 70% of Americans use dietary supplements daily, yet these products are not required to be approved by the FDA before being sold, leading to potential safety concerns.

While many supplements are widely consumed, there is limited evidence supporting their health benefits in well-nourished adults, and some can cause significant toxicity or interact negatively with prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

A study of 1017 British soldiers during Op TELIC found that 41% reported using dietary and exercise supplements, with whey protein, amino acids, and creatine being the most common, highlighting a significant prevalence of supplement use in military settings.

The concerning finding of 1.4% of soldiers admitting to current anabolic steroid use underscores the need for increased education on the potential health risks associated with such supplements, as well as the importance of promoting safe practices among military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administration of exercise and dietary supplements in deployed British military personnel during Operation TELIC 13. Boos, CJ., Wheble, GA., Campbell, MJ., et al.[2022]

Approximately 70% of military personnel use dietary supplements, which is significantly higher than the 50% usage rate in the general civilian population, potentially increasing their risk of adverse events.

The US Department of Defense has implemented measures like Operation Supplement Safety to educate military personnel about safe supplement use and to monitor and report adverse events associated with dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. Deuster, PA., Lieberman, HR.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Taking Stock of Dietary Supplements' Harmful Effects on Children, Adolescents, and Young Adults. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Self-administration of exercise and dietary supplements in deployed British military personnel during Operation TELIC 13. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Protecting military personnel from high risk dietary supplements. [2017]

6. Canada pubmed.ncbi.nlm.nih.gov

Effects of a daily mixed nutritional supplement on physical performance, body composition, and circulating anabolic hormones during 8 weeks of arduous military training. [2022]

7. South Africa pubmed.ncbi.nlm.nih.gov

Nutrient intake and dietary supplementation in body-builders. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of Four Weeks of a Multi-Ingredient Performance Supplement on Muscular Strength, Body Composition, and Anabolic Hormones in Resistance-Trained Young Men. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

PAKs supplement improves immune status and body composition but not muscle strength in resistance trained individuals. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of vitamin and amino acid supplements on human performance during heavy mental and physical work. [2008]