Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory Biomarkers and Epigenetic Changes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Plasma Proteomic Changes
Study Overview
Brief Summary
This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory biomarkers and epigenetic age.
Detailed Description
The objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. The primary objective of this study is to assess the effect of the formulation, LLP-01, on inflammatory proteomic biomarkers and epigenetic changes. Adverse events will be self-monitored by participants and will be reported. Changes in weight/calculated BMI and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 50-75 years of age
- •Any sex / gender
- •All ethnicities
- •Able to participate in a 2 month trial
- •Able to provide informed consent
- •Participant must be able to comply with treatment plan and laboratory tests
- •Can swallow 00 size capsules
Exclusion Criteria
- •Any clinically diagnosed medical disease or disorder that requires prescribed medication(s)
- •Currently on any anticoagulant medicines, such as warfarin
- •Planned surgical procedure during study period
- •Consumption of any supplements within the last 30 days that include the following botanicals/ingredients: green tea extract, Ashwagandha, Fisetin, Curcumin/Turmeric extract, Rosemary extract, Cordyceps, Ginseng
- •Allergy or other sensitivity to any of the botanicals in the investigated product
- •Currently or have been sick (bacterial or viral infection) in the last 14 days
- •Alcoholism or drug addiction
- •Participation in a clinical research trial within 30 days prior to enrollment in this trial
- •Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
- •Unable or unwilling to provide required blood sample for testing and for use in a scientific publication (personal information undisclosed)
- •Participants with any condition that may preclude venipuncture/ venous blood draw
Outcomes
Primary Outcomes
Plasma Proteomic Changes
Time Frame: Change from baseline to 60 days and compared to placebo
Serum proteomic test to measure significant effects on any of the plasma proteins that will be analyzed. These proteins represent inflammatory and immune responses, as well as metabolic functions.
Secondary Outcomes
- Weight/BMI(Change from baseline to 60 days and compared to placebo)
- Well-being(Change from baseline to 60 days and compared to placebo)
- Grip Strength(Change from baseline to 60 days and compared to placebo)
- Epigenetic Age(Change from baseline to 60 days and compared to placebo)