Supplement Combination for Healthy Subjects

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a combination of supplements affects sleep quality and stress levels in healthy adults. Participants will test different supplement combinations in the morning (AM Active Supplement Combination) and evening (PM Active Supplement Combination) to identify the most effective one. Ideal candidates are healthy individuals who exercise regularly and have not recently changed their supplement routine. Participants must own an Apple device with the latest iOS software.

As an unphased trial, this study provides a unique opportunity to explore personalized supplement combinations for improved well-being.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the safety of the AM Active Supplement Combination, which includes Ashwagandha and Rhodiola rosea, has been studied in various settings. These ingredients are common in dietary supplements and are usually well-tolerated. However, some studies, such as those involving military personnel, have reported unexpected negative effects with similar products.

For the PM Active Supplement Combination, specific safety information remains limited. While dietary supplements are generally considered safe, less is known about their long-term effects. Participants should also be aware of potential interactions with other medications or supplements.

Overall, since this trial is not in its early stages, some evidence suggests these supplements are generally safe. However, detailed safety information for these specific combinations may still be developing. Participants should consider this and discuss any concerns with the trial team.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these supplement combinations because they offer a fresh approach to enhancing overall health in healthy individuals. Unlike traditional supplements that may target single nutrients, these combinations feature a blend of active ingredients tailored for morning or evening use, potentially optimizing the body's natural rhythms. This tailored approach could lead to more effective nutrient absorption and better support for the body's daily functions, setting this trial apart from existing one-size-fits-all supplements. Additionally, the use of both active and placebo comparisons helps to thoroughly assess the true impact of these combinations, providing clearer insights into their potential benefits.

What evidence suggests that this trial's supplement combinations could be effective for improving sleep quality and reducing stress?

This trial will evaluate different supplement combinations for their effects on sleep and stress in healthy subjects. Participants will join one of several treatment arms, which include combinations of active supplements and placebos. Studies have shown that some supplements can improve sleep quality and reduce stress. For example, one study found that a mix of S-adenosyl methionine (SAMe) and probiotics improved mood, potentially aiding stress relief. Another study showed that a supplement with multiple nutrients reduced inflammation, which can indirectly enhance sleep and stress levels. While research on these specific combinations continues, the potential benefits are based on how these ingredients function in the body. Scientists are exploring how these supplements might aid sleep and stress, and early results are promising.12678

Are You a Good Fit for This Trial?

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
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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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: AM active, PM activeExperimental Treatment1 Intervention
Group II: AM active, PM placeboActive Control1 Intervention
Group III: AM placebo, PM activeActive Control1 Intervention
Group IV: AM placebo, PM placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials
233
Recruited
122,000+

Momentous

Collaborator

Trials
1
Recruited
120+

Published Research Related to This Trial

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.
Protecting military personnel from high risk dietary supplements.Deuster, PA., Lieberman, HR.[2017]
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.
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.
Adverse Effects of Nutraceuticals and Dietary Supplements.Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

Citations

Supplement Combination on Stress and SleepThe purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults. Official ...
Supplement Combination for Healthy SubjectsThis trial is for healthy adults interested in exploring how a combination of supplements might affect their sleep quality and stress levels. Specific ...
Supplement Combination on Stress and SleepThe purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults. Official ...
Efficacy of a food supplement based on S-adenosyl ...The aim of this study is to demonstrate the efficacy of a food supplement based on a combination of S-adenosyl methionine (SAMe, 200 mg/day) and probiotics.
A multi-nutrient supplement reduced markers of inflammation ...Conclusions. A multi-nutrient supplement is effective in improving inflammatory status in both men and women, markers of pain, joint pain, ...
Supplement Combination on Stress and SleepThe purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy ...
The US Military Dietary Supplement Use StudyIn descending order, AEs in the baseline phase were most often reported for combination products, prohormones, protein/AAs, individual vitamins/minerals, MVM, ...
The Military Dietary Supplement Use StudyThis study presents contemporary data collected from a very large at-risk population on potentially haz- ardous categories of DSs. J Acad Nutr ...
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