Wellness Products for Fatigue

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if health and wellness products can reduce fatigue. Participants will use either one of several energy products, such as Energy Active Study Product 1.1 or Energy Active Study Product 1.2, or a placebo (a substance without active ingredients) to compare effects. Ideal candidates for this trial are U.S. residents who frequently feel tired and seek more energy. As an unphased trial, it offers participants the chance to explore new ways to boost energy levels.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study products. These include blood thinners, blood pressure meds, anxiety or depression meds, and others. It's best to discuss your specific medications with the study team.

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

Research shows that the Energy Active Study Products being tested for fatigue are generally easy for most people to handle. Previous studies have found that these products rarely cause serious side effects. Most participants report only mild issues, similar to those experienced when trying a new vitamin or supplement.

For Active Products 1.1 and 1.2, past participants reported no major problems. These studies were carefully designed to ensure reliable results by using a method where neither the participants nor the researchers knew who received the actual product or a placebo.

Similarly, Active Products 4.1, 4.2, and 4.3 have been tested in comparable studies. These studies did not find any major safety concerns, but they advise caution for people with heart, liver, or kidney issues.

Active Product 3.1 and products under the label 5, such as 5.1.1, 5.2.1, 5.3.1, and 5.3.2, do not yet have detailed safety information available. However, because these trials have reached a certain stage, the products have likely shown an acceptable safety level in earlier tests.

These trials are ongoing to collect more information, but current findings suggest that these wellness products are safe for most people. Always consider personal health conditions when deciding if a trial is right. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for fatigue because they explore new formulations that could offer unique benefits over standard options like caffeine or prescription stimulants. Unlike typical treatments, the Energy Active Study Products are designed to potentially improve energy levels with less risk of side effects like jitteriness or dependency. The innovative aspect lies in their different forms and potentially novel active ingredients, which could provide a more sustainable boost in energy without the common crash associated with current stimulants.

What evidence suggests that this trial's treatments could be effective for fatigue?

Research has shown that Energy Active Study Products, which participants in this trial may receive, might help reduce tiredness. Previous studies have found that similar wellness products can boost energy and alleviate fatigue. Specifically, several trials have demonstrated that using these products for a few weeks can improve endurance and reduce tiredness. One study found that taking a vitamin B complex for 28 days significantly improved exercise performance and reduced fatigue. These findings suggest that the Energy Active Products in this trial could effectively manage tiredness. ^{2 4 6 7 8}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 21 in the U.S. who want more energy and can improve their health by at least 20%. They must be willing to take a product without knowing if it's active or placebo. Excluded are those on certain medications, heavy drinkers, with recent major illness/surgery, heart/liver/kidney disease, or pregnant/breastfeeding.

Inclusion Criteria

I am 21 years or older and understand my participation may involve sex-specific aspects.

Resides in the United States

I want to feel more energetic and less tired.

Exclusion Criteria

I cannot provide a valid US address and mobile number.

I do not have severe heart, liver, or kidney disease that could make the study unsafe for me.

I am taking medication that could dangerously interact with the study's treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment through a final survey

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Energy Active Study Product 1.1 Usage
• Energy Active Study Product 1.2 Usage
• Energy Placebo Control Form 1

Trial Overview The study tests two different 'Energy Active' products against a placebo to see which one better reduces fatigue. Participants won't know what they're taking. It's randomized (assigned by chance) and double-blind (neither researchers nor participants know who gets what).

How Is the Trial Designed?

Group I: Active Product 5.3.2 Experimental Treatment 1 Intervention

Energy Product Form 5.3 - active product 2

Group II: Active Product 5.3.1 Experimental Treatment 1 Intervention

Energy Product Form 5.3 - active product 1

Group III: Active Product 5.2.1 Experimental Treatment 1 Intervention

Energy Product Form 5.2 - active product 1

Group IV: Active Product 5.1.1 Experimental Treatment 1 Intervention

Energy Product Form 5.1 - active product 1

Group V: Active Product 4.3 Experimental Treatment 1 Intervention

Energy Product Form 4 - active product 3

Group VI: Active Product 4.2 Experimental Treatment 1 Intervention

Energy Product Form 4 - active product 2

Group VII: Active Product 4.1 Experimental Treatment 1 Intervention

Energy Product Form 4 - active product 1

Group VIII: Active Product 3.1 Experimental Treatment 1 Intervention

Energy Product Form 3 - active product 1

Group IX: Active Product 2.1 Experimental Treatment 1 Intervention

Energy Product Form 2 - active product 1

Group X: Active Product 1.2 Experimental Treatment 1 Intervention

Energy Product Form 1 - active product 2

Group XI: Active Product 1.1 Experimental Treatment 1 Intervention

Energy Product Form 1 - active product 1

Group XII: Placebo Control 2 Placebo Group 1 Intervention

Energy Product Form 2 - control

Group XIII: Placebo Control 4 Placebo Group 1 Intervention

Energy Product Form 4 - control

Group XIV: Placebo Control 1 Placebo Group 1 Intervention

Energy Product Form 1 - control

Group XV: Placebo Control 3 Placebo Group 1 Intervention

Energy Product Form 3 - control

Group XVI: Placebo Control 5.1.0 Placebo Group 1 Intervention

Energy Product Form 5.1 - control

Group XVII: Placebo Control 5.3.0 Placebo Group 1 Intervention

Energy Product Form 5.3 - control

Group XVIII: Placebo Control 5.2.0 Placebo Group 1 Intervention

Energy Product Form 5.2 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

A study involving 21 women with breast cancer showed that adherence to an Individualized Sleep Promotion Plan (ISPP) was high (77%-88%), which included strategies like sleep hygiene and relaxation therapy, leading to generally positive sleep outcomes after chemotherapy.

Participants experienced low levels of fatigue (2.9-3.5 on a 0-10 scale) and maintained good sleep efficiency (82%-92%), although nighttime awakenings were higher than desired, indicating that behavioral techniques for sleep promotion can be beneficial post-chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. Berger, AM., VonEssen, S., Kuhn, BR., et al.[2015]

In a study of 17 men, the dietary supplement Fatigue Reviva™ significantly improved fatigue levels after 30 days of daily use, as indicated by a reduction in the Chalder fatigue score.

65% of participants felt that the supplement improved their health, although some reported gastrointestinal symptoms likely related to its fructooligosaccharide content, suggesting the need for further product refinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a complex amino acid supplement, Fatigue Reviva™, for oral ingestion: initial evaluations of product concept and impact on symptoms of sub-health in a group of males. Dunstan, RH., Sparkes, DL., Roberts, TK., et al.[2021]

In a study with 15 participants, the energy drink Amino Impact significantly increased time to exhaustion during treadmill exercise by 12.5% compared to a placebo, indicating its potential efficacy for enhancing endurance.

Participants consuming Amino Impact reported higher levels of focus and energy, and lower feelings of fatigue before and during exercise, suggesting that the drink may improve subjective exercise experience as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved time to exhaustion following ingestion of the energy drink Amino Impact. Walsh, AL., Gonzalez, AM., Ratamess, NA., et al.[2022]

In a study involving 84 patients with advanced cancer, an open-labeled placebo (OLP) significantly reduced cancer-related fatigue (CRF) after one week compared to a waitlist control, with a mean improvement of 6.6 points on the FACIT-F scale versus 2.1 points for the control group.

The benefits of the OLP were sustained for four weeks after the initial treatment, indicating its potential efficacy in managing fatigue in advanced cancer patients, with no significant adverse effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial. Yennurajalingam, S., Azhar, A., Lu, Z., et al.[2023]

Energy products, which often contain caffeine as the main active ingredient, have surged in popularity, with users believing they enhance concentration and alertness.

The additional ingredients in these products, labeled as 'energy blends,' lack clear evidence of providing any extra benefits beyond what caffeine alone offers, highlighting the need for further research on their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of energy drink ingredients on mood and cognitive performance. Childs, E.[2018]

Panax ginseng has been traditionally used in Chinese medicine for its potential to combat fatigue, which affects millions globally due to various causes like physical labor and chronic stress.

The review highlights that P. ginseng may enhance energy metabolism and exhibit antioxidant and anti-inflammatory properties, contributing to its anti-fatigue effects observed in both animal models and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Panax ginseng C.A. Meyer as a Herb for Anti-Fatigue: An Effects and Mechanisms Review. Lu, G., Liu, Z., Wang, X., et al.[2021]

The inpatient energy management education (IEME) program, a novel intervention for people with multiple sclerosis (pwMS), showed significant improvements in self-efficacy regarding energy conservation strategies and physical functioning quality of life, with a large effect size (Cohen's d: 1.32).

The feasibility study involved 47 participants and demonstrated a low dropout rate (4.2%), indicating that the IEME program is well-accepted and can be effectively implemented in a clinical setting, supporting the need for a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-week inpatient energy management education (IEME) for persons with multiple sclerosis-related fatigue: Feasibility of a randomized clinical trial. Hersche, R., Weise, A., Michel, G., et al.[2020]

A systematic review of 8 randomized clinical trials and 30 animal studies found that Panax ginseng C. A. Mey (PGC) significantly reduces fatigue compared to placebo, showing improvements in various fatigue scales and physiological markers.

PGC appears to be safe, with no significant difference in adverse effects compared to placebo, and its anti-fatigue effects may be due to mechanisms like antioxidant stress reduction, improved carbohydrate metabolism, and neuroprotection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Preclinical Systematic Review of Panax ginseng C. A. Mey and Its Compounds for Fatigue. Jin, TY., Rong, PQ., Liang, HY., et al.[2022]

A new multidimensional Patient Reported Outcome measure, the Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 (MDF-Fibro-17), was developed to assess the complex nature of fatigue in fibromyalgia, based on qualitative and quantitative data from 145 patients across multiple studies.

The MDF-Fibro-17 captures five key domains of FM-related fatigue: Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function, indicating a comprehensive approach to understanding and measuring fatigue in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional daily diary of fatigue-fibromyalgia-17 items (MDF-fibro-17). part 1: development and content validity. Morris, S., Li, Y., Smith, JAM., et al.[2018]

A study involving 50 cancer patients demonstrated that using a 7-day fatigue diary was highly feasible, with 94% of participants completing it, which helped them better understand and manage their fatigue.

After using the diary, patients reported feeling less helpless about their fatigue and were more proactive in discussing it with their healthcare providers, indicating that fatigue diaries can significantly enhance self-management and awareness of fatigue patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cancer patients' perspective on feasibility of using a fatigue diary and the benefits on self-management: results from a longitudinal study. Milzer, M., Steindorf, K., Reinke, P., et al.[2022]

The FAtigue MOnitoring System (FAMOS) effectively distinguishes between fatigued multiple sclerosis (MS) patients and healthy controls by measuring various physiological parameters, indicating its potential as a diagnostic tool.

Fatigued MS patients exhibit signs of vagus nerve dysfunction and an imbalance in their autonomic nervous system during cognitive and physical stress tests, suggesting that fatigue in MS may be linked to underlying physiological changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigued patients with multiple sclerosis can be discriminated from healthy controls by the recordings of a newly developed measurement system (FAMOS): a pilot study. Yu, F., Bilberg, A., Dalgas, U., et al.[2012]

In the PACE trial involving 641 participants with chronic fatigue syndrome, serious adverse events were rare, while non-serious adverse events were common, with no significant differences in their occurrence across different treatment groups.

Physical deterioration was most frequently reported after adaptive pacing therapy (APT), affecting 25% of participants, indicating that while treatments did not significantly differ in adverse events, APT may be associated with a higher risk of worsening physical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. Dougall, D., Johnson, A., Goldsmith, K., et al.[2022]

The pilot study tested an energy conservation program for managing fatigue in 23 people with multiple sclerosis, showing that the program was feasible and well-received by participants, despite some challenges in completing activities.

Recruitment was a challenge, with nearly 30% of potential participants declining due to transport and time issues, indicating that future studies should address these logistical barriers to improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy conservation for fatigue management in multiple sclerosis: a pilot randomized controlled trial. García Jalón, EG., Lennon, S., Peoples, L., et al.[2012]

A 12-week self-management intervention focused on energy conservation significantly reduced fatigue in 19 Thai women with breast cancer undergoing chemotherapy, with a notable difference compared to the control group (p = 0.008).

Participants reported high satisfaction with the intervention, indicating that it is a feasible and effective strategy for oncology nurses to implement in managing fatigue during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management Energy Conservation for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study. Naraphong, W., Barton, D.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06201689

Radicle Energy 24: A Study of Health and Wellness ... This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06999655

Radicle Energy: A Study Assessing the Impact of Health ... This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

3. ctv.veeva.com ctv.veeva.com/study/radicle-energy-24-a-study-of-health-and-wellness-products-on-fatigue-and-related-health-outcomes

Radicle Energy 24: A Study of Health and Wellness Products ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes.

4. withpower.com withpower.com/trial/phase-fatigue-8-2025-c243f

Energy Active Product for Fatigue · Info for Participants Trial Overview The study is examining an 'Energy Active Product 1' against a placebo to see if it helps with fatigue. Participants won't know which one they're ...

5. ctv.veeva.com ctv.veeva.com/study/radicle-energy2-a-study-of-health-and-wellness-products-on-fatigue-and-other-health-outcomes

Radicle Energy2: A Study of Health and Wellness Products on ... A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07166523

Radicle Energy™ 24_RCA: A Study Assessing the Impact ... Radicle Energy™ 24_RCA: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07036679

Radicle Energy 25: A Study Assessing the Impact of Health ... A Randomized, Double-Blind, Placebo Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06201689/radicle-energy-24-a-study-of-health-and-wellness-products-on-fatigue-and-related-health-outcomes

Radicle Energy 24: A Study of Health and Wellness ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health ...