Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT05234203
Eligibility Criteria:
Inclusion Criteria:
* Men and women of any ethnicity.
* Age Range - 18 - 85 (inclusive)
* Participant must be able to comply with treatment plan and laboratory tests including ability and willingness to perform home venous blood draw using Tasso device.
* Participant must be able to read, write and speak English fluently
* Participant must have an established primary care provider
* Participant must be willing and able to consume 4 capsules per day throughout the duration of study period
Exclusion Criteria:
* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Known immune system issues or immunodeficiency disease
* History of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Participants infected with hepatitis C or HIV
* Body Mass Index (BMI) greater than or equal to 40 kilograms per meter squared
* Presence of active infection in previous 4 weeks
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the Clinical Investigator would render a participant unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
* Current or previous use of known prescription immunomodulating products (e.g. glucocorticoids, tumor necrosis factor (TNF)-alpha inhibitors) in the month prior to the start of the trial.
* Taking a concentrated polyphenol-focused supplement in the month prior to the start of the trial (e.g., quercetin, Epigallocatechin gallate (EGCG), resveratrol, curcumin, berberine, soy isoflavones, rutin, luteolin fisetin) or products that contain Tartary buckwheat
* A known history of blood dyscrasias including coagulopathy
* Current use of prescription anticoagulant medications
* Current pregnancy, planned attempts to conceive during study period or sexually active females not using contraception, as well as lactating/nursing females
* Current job that requires night-shift work
* Known allergy to polyphenolics
* Known allergy to buckwheat or Tartary buckwheat
* Investors or immediate family of investors in Big Bold Health
* Any person deemed by Clinical Investigator as low likelihood of complying with study protocol (e.g. evidence of history of non-compliance, history of poor follow-up, multiple or complex scheduling conflicts).
* Planned surgical procedure during study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05234203
Study Brief:
Protocol Section:
NCT05234203