Essential Oils for Healthy Subjects

Overseen By Allison Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Breastfeeding, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Natural Compound A and Natural Compound B in the clinical trial 'Essential Oils for Healthy Subjects'?

Research shows that essential oils, which are similar to Natural Compound A and B, have health benefits like reducing inflammation, boosting the immune system, and improving mood and cognitive performance. These benefits suggest that the treatment might help improve overall well-being in healthy subjects. ^{1 2 3 4 5}

Are essential oils generally safe for human use?

Essential oils are generally considered safe when used properly, but they can cause toxic reactions if not used correctly. It's important to follow recommended doses and be cautious, especially for children and pregnant women, as they are more vulnerable to potential adverse effects. ^{1 2 6 7 8}

How do essential oils differ from other treatments for maintaining health?

Essential oils are unique because they are natural plant extracts that can be used in various ways, such as inhalation, massage, or oral intake, to promote health. Unlike many conventional treatments, they offer a wide range of benefits, including antimicrobial, anti-inflammatory, and mood-enhancing effects, and can be used as part of diet supplements or aromatherapy. ^{1 2 9 10 11}

What is the purpose of this trial?

The purpose of this study is to explore the positive, holistic health outcomes resulting from regular exposure to naturally occurring compounds predicted to have health benefits. The researchers hope to learn how the human body is influenced by regular exposure to these compounds.

Research Team

Michael Snyder, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 who can read, speak, and understand English and live in the US. It's not suitable for those who are pregnant or breastfeeding, have epilepsy, mental incapacity, cognitive impairments, or allergies to certain plant families like redwoods and cedars.

Inclusion Criteria

You possess a proficient understanding of the English language.

You are residing in the United States.

Exclusion Criteria

You are currently breastfeeding.

I have epilepsy.

You are allergic to certain types of plants like redwoods, junipers, cypress, cedar, fir, and sequoia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cycle 1

Participants use diffused 'Natural Compound A' (essential oil) in a diffuser every night when sleeping

4 weeks

Weekly visits for monitoring

Cycle 2

Wash-out period where participants do not use compounds/diffuser

4 weeks

Weekly visits for monitoring

Cycle 3

Participants use diffused 'Natural Compound B' (essential oil) in a diffuser every night when sleeping

4 weeks

Weekly visits for monitoring

Cycle 4

Post-intervention observation period where participants do not use compounds/diffuser

4 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Natural Compound A
• Natural Compound B

Trial Overview The study tests two natural compounds (essential oils A & B) to see if they promote holistic health benefits through regular exposure. Participants will not know which compound they're receiving as part of the study's design.

Participant Groups

Group I: Group C- Natural Compound C to Natural Compound A to Natural Compound B Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Group II: Group B- Natural Compound B to Natural Compound C to Natural Compound A Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Group III: Group A- Natural Compound A to Natural Compound B to Natural Compound C Experimental Treatment 3 Interventions

* Cycle 1 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) * Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Essential oils (EOs) have a wide range of potential health benefits, including support for digestive health, metabolic regulation, and immune system enhancement, as highlighted by recent clinical trials and preclinical research.

Specific EOs, such as green and black cumin, bergamot, and peppermint, show promise in managing conditions like irritable bowel syndrome, inflammatory bowel disease, and even neuroprotection, suggesting they could be valuable in functional foods and dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant Essential Oils as Healthy Functional Ingredients of Nutraceuticals and Diet Supplements: A Review. Matera, R., Lucchi, E., Valgimigli, L.[2023]

Essential oils (EOs) have a wide range of therapeutic activities, including anti-inflammatory, antimicrobial, and analgesic effects, which can work both individually and synergistically to promote health.

To ensure the safety and efficacy of EOs, it is crucial to analyze their complex chemical profiles using gas-chromatography-mass detection methods, which helps establish standards for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils in medicine: principles of therapy. Pisseri, F., Bertoli, A., Pistelli, L.[2008]

Natural essential oil constituents from aromatic herbs and dietary plants have various mechanisms that contribute to cancer prevention and treatment, including antioxidant and antimutagenic properties, immune function enhancement, and modulation of drug resistance.

The review highlights the importance of these constituents' structural categories and their molecular anticancer mechanisms, suggesting their potential as effective chemopreventive agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticancer activity of essential oils: a review. Bhalla, Y., Gupta, VK., Jaitak, V.[2014]

Essential oils (EOs) possess antibacterial, antiviral, and anti-inflammatory properties, making them valuable for both treating and preventing various diseases, as well as for use in cosmetics and food.

The complex mixture of compounds in EOs allows for multi-target activity, which may enhance their therapeutic effects compared to single compounds, indicating their potential role in integrative medicine and future health applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential Oils as Multicomponent Mixtures and Their Potential for Human Health and Well-Being. Bunse, M., Daniels, R., Gründemann, C., et al.[2023]

In a pilot study involving 40 patients in a rheumatology ward, nursing interventions that included essential oils led to significant improvements in specific aspects of well-being, although they did not enhance overall general well-being.

The study suggests that nursing with essential oils is more effective than standard nursing without oils, as patients reported more positive experiences related to their care when essential oils were used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nursing without and with essential oils: a controlled study of patients in an acute rheumatologic department]. Christen, L., Christen, S., Waldmeier, V., et al.[2019]

A new guide has been created to assess the safety of essential oils used as flavor ingredients, focusing on their complete chemical composition and the variability in their mixtures.

The guide evaluates the safety of essential oil constituents by organizing them into congeneric groups based on their chemical properties, ensuring that all potentially harmful components are thoroughly assessed while allowing for flexibility in evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: essential oils. Smith, RL., Cohen, SM., Doull, J., et al.[2006]

A new tiered approach for determining safe recommended doses of essential oils (EOs) as food supplements has been proposed, focusing on the toxicological evaluation of each constituent's concentration.

This methodology assesses the genotoxic potential of constituents and establishes safety margins, ensuring that recommended doses are safe without requiring new animal testing, thus promoting safer consumption of EOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicological safety assessment of essential oils used as food supplements to establish safe oral recommended doses. Sartori Tamburlin, I., Roux, E., Feuillée, M., et al.[2022]

Essential oils, while popular for their therapeutic uses, can pose safety risks, including toxic reactions from oral or topical use, especially in vulnerable populations like children and pregnant women.

The regulation of essential oils is complex, with varying classifications (medicine, food supplement, etc.) in Belgium, and many essential oils lack sufficient clinical trial data to support their efficacy, despite public misconceptions about their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Essential oils: good advice by the pharmacist is necessary]. Vandersteen, L.[2018]

Essential oils are complex mixtures derived from various plant sources, and their composition can vary significantly based on factors like the plant family, extraction method, and environmental conditions.

Despite being natural substances, essential oils can be toxic, highlighting the need for careful evaluation and regulation to ensure their safe use in cosmetics, drugs, and food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential oils: renewal of interest and toxicity. Vigan, M.[2022]

Essential oils (EOs) are concentrated natural plant products with various applications in modern medicine, including treatment for respiratory diseases, pain management, and stress relief.

While EOs can be beneficial, there are risks associated with their use, such as allergic reactions, overdosing, and variability in substance quality, which must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aromatherapy - From Traditional and Scientific Evidence into Clinical Practice]. Steflitsch, W.[2018]

Essential oils, derived from plants, have gained attention for their germicidal, antifungal, antiviral, and anti-parasitic properties, suggesting they could be a source of new therapeutic agents alongside traditional treatments.

While essential oils may positively influence health and mental well-being, there is a risk of side effects and the potential for developing resistant pathogens, highlighting the need for quality standards in their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Essential Oils on Infectious Agents. Piątkowska, E., Rusiecka-Ziółkowska, J.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Plant Essential Oils as Healthy Functional Ingredients of Nutraceuticals and Diet Supplements: A Review. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Essential oils in medicine: principles of therapy. [2008]

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

Anticancer activity of essential oils: a review. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Essential Oils as Multicomponent Mixtures and Their Potential for Human Health and Well-Being. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Nursing without and with essential oils: a controlled study of patients in an acute rheumatologic department]. [2019]

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

A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: essential oils. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Toxicological safety assessment of essential oils used as food supplements to establish safe oral recommended doses. [2022]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Essential oils: good advice by the pharmacist is necessary]. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Essential oils: renewal of interest and toxicity. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Aromatherapy - From Traditional and Scientific Evidence into Clinical Practice]. [2018]

11. Poland pubmed.ncbi.nlm.nih.gov

Influence of Essential Oils on Infectious Agents. [2018]