NCT05508529

Brief Summary

The objective of this proposal is to recruit 20 healthy subjects per ingredient arm (5 arms x 20 subjects; N= 120 total) to participate in a research study investigating the effects of dietary supplementation for one-month with different dietary supplement formulations (versus placebo; N=20) that may have benefits for supporting respiratory health, psychological stress, and quality of life. Supplements to be studied (all are commercially available):

  1. 1.Chaga (mushroom extract)
  2. 2.Arava (algae concentrate)
  3. 3.Thymoquin (black cumin seed oil)
  4. 4.Thymoquin + Astaxanthin (antioxidant carotenoid)
  5. 5.Thymoquin + Omega 3 (fish oil)
  6. 6.Placebo (corn starch)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

August 13, 2022

Last Update Submit

August 18, 2022

Conditions

Stress

Outcome Measures

Primary Outcomes (4)

  • Psychological Mood State (e.g. stress)

    "Global Well-Being" index as collected by the validated Profile of Mood States Survey (POMS)

    1 month

  • Health Log

    total number of subjective upper respiratory tract complaints per subject (e.g. sore throat, cough, etc)

    1 month

  • Stress Hormones

    Salivary Cortisol (ng/ml)

    1 month

  • Microbiome Balance

    Streptococcus thermophilus (relative abundance)

    1 month

Study Arms (6)

Chaga Mushroom

ACTIVE COMPARATOR

Chaga mushroom extract (1 capsule daily) Active ingredients: 480mg chaga mushroom extract Inactive ingredients: none

Dietary Supplement: Chaga Mushroom

Algae Extract

ACTIVE COMPARATOR

Algae Concentrate (2 tablets daily) Active ingredients: 8mg algae concentrate Inactive ingredients: none

Dietary Supplement: Algae Extract

Black Cumin Seed Oil

ACTIVE COMPARATOR

Black cumin seed oil (1 softgel daily) Active ingredients: 500mg black cumin seed oil Inactive ingredients: medium chain triglyceride (MCT) oil

Dietary Supplement: Black Cumin Seed Oil

Black Cumin Seed Oil + Astaxanthin

ACTIVE COMPARATOR

Black Cumin Seed Oil + Astaxanthin (3 softgels daily) Active ingredients: 500mg black cumin seed oil + 8mg astaxanthin oleoresin Inactive ingredients: medium chain triglyceride (MCT) oil

Dietary Supplement: Black Cumin Seed Oil + Astaxanthin

Black Cumin Seed Oil + Omega 3

ACTIVE COMPARATOR

Black Cumin Seed Oil + Omega 3 (3 softgels daily) Active ingredients: 500mg black cumin seed oil + 1200mg omega3 from 1500mg fish oil Inactive ingredients: none

Dietary Supplement: Black Cumin Seed Oil + Omega 3

Placebo

PLACEBO COMPARATOR

Placebo (1 capsule daily) Inactive ingredients: 500 mg Cornstarch/Maltodextrin

Dietary Supplement: Placebo

Interventions

Chaga MushroomDIETARY_SUPPLEMENT

Effect of chaga on immune/mood support

Chaga Mushroom
Algae ExtractDIETARY_SUPPLEMENT

Effect of algae extract on immune/mood support

Algae Extract
Black Cumin Seed OilDIETARY_SUPPLEMENT

Effect of black cumin seed oil on immune/mood support

Black Cumin Seed Oil
Black Cumin Seed Oil + AstaxanthinDIETARY_SUPPLEMENT

Effect of Black Cumin Seed Oil + Astaxanthin blend on immune/mood support

Black Cumin Seed Oil + Astaxanthin
Black Cumin Seed Oil + Omega 3DIETARY_SUPPLEMENT

Effect of Black Cumin Seed Oil + Omega3 blend on immune/mood support

Black Cumin Seed Oil + Omega 3
PlaceboDIETARY_SUPPLEMENT

Placebo control

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and Females age 18 to 60 years
  • Ability to complete strenuous off-road trail run, and planning to do so regardless of the study
  • Willingness to consume the dietary supplements under investigation
  • Willingness to undertake all protocol measurements and training regimens
  • Ability to understand and sign the informed consent form (ICF)

You may not qualify if:

  • Any supplements or medications that are stress/immune-suppressive or stress/immune-stimulant (e.g. herbal stimulants).
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3 Waves Wellness, LLC

Plymouth, Massachusetts, 02360, United States

Location

Related Publications (4)

  • Talbott SM, Talbott JA, Talbott TL, Dingler E. beta-Glucan supplementation, allergy symptoms, and quality of life in self-described ragweed allergy sufferers. Food Sci Nutr. 2013 Jan;1(1):90-101. doi: 10.1002/fsn3.11. Epub 2014 Jan 8.

    PMID: 24804018BACKGROUND

  • Talbott SM, Talbott JA, George A, Pugh M. Effect of Tongkat Ali on stress hormones and psychological mood state in moderately stressed subjects. J Int Soc Sports Nutr. 2013 May 26;10(1):28. doi: 10.1186/1550-2783-10-28.

    PMID: 23705671BACKGROUND

  • Talbott SM, Talbott JA. Baker's yeast beta-glucan supplement reduces upper respiratory symptoms and improves mood state in stressed women. J Am Coll Nutr. 2012 Aug;31(4):295-300. doi: 10.1080/07315724.2012.10720441.

    PMID: 23378458BACKGROUND

  • Talbott SM, Talbott JA, Pugh M. Effect of Magnolia officinalis and Phellodendron amurense (Relora(R)) on cortisol and psychological mood state in moderately stressed subjects. J Int Soc Sports Nutr. 2013 Aug 7;10(1):37. doi: 10.1186/1550-2783-10-37.

    PMID: 23924268BACKGROUND

MeSH Terms

Interventions

Nigella sativa oilastaxanthineDocosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Shawn Talbott, PhD

    3 Waves Wellness

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
randomized, placebo-controlled, with coded bottles for each group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: treatment (5 dietary supplement blends) versus placebo (control)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 19, 2022

Study Start

July 1, 2020

Primary Completion

March 1, 2021

Study Completion

July 1, 2021

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

data will be available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
upon study completion
Access Criteria
data will be available upon request

Locations

US(1)