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

2752 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Energy Active Study Product 1.1 Usage, Energy Active Study Product 1.2 Usage, Energy Placebo Control Form 1 for fatigue?

There is research suggesting that energy management and conservation strategies can help manage fatigue in conditions like multiple sclerosis and cancer. These strategies may be relevant to the treatment being studied, as they focus on managing energy levels to reduce fatigue. ^{1 2 3 4 5}

Is the Wellness Product for Fatigue safe for humans?

The research articles provided do not contain specific safety data for the Wellness Product for Fatigue or its related names. ^{3 6 7 8 9}

How does the treatment for fatigue in the Wellness Products for Fatigue trial differ from other treatments?

The treatment in the Wellness Products for Fatigue trial is unique because it involves the use of Panax ginseng, a traditional herbal remedy known for its anti-fatigue properties, which works by enhancing energy metabolism and reducing inflammation. This differs from typical energy drinks that primarily rely on caffeine, as Panax ginseng offers a broader range of benefits without the reliance on stimulants. ^{10 11 12 13 14}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Multidimensional daily diary of fatigue-fibromyalgia-17 items (MDF-fibro-17). part 1: development and content validity. [2018]

2. Netherlands 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Energy conservation for fatigue management in multiple sclerosis: a pilot randomized controlled trial. [2012]

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

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. [2015]

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

Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. [2022]

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

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

8. Germany 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. [2022]

9. England 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. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical and Preclinical Systematic Review of Panax ginseng C. A. Mey and Its Compounds for Fatigue. [2022]

11. England 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. [2021]

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

Improved time to exhaustion following ingestion of the energy drink Amino Impact. [2022]

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

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

14. Switzerland pubmed.ncbi.nlm.nih.gov

Recent Advances in Panax ginseng C.A. Meyer as a Herb for Anti-Fatigue: An Effects and Mechanisms Review. [2021]