Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory Biomarkers and Epigenetic Changes.

Conditions
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Aging, Inflammation

Intervention / Treatment
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* Dietary Supplement: LLP-01
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 month, double blind placebo controlled study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants in this arm will receive a herbal capsule formulation, called LLP-01, consisting of 2 capsules taken once daily without food for 60 days. The capsules contain extracts from naturally occurring plant species, including Withania somnifera, Rosmarinus officinalis, Curcuma longa, Cotinus coggygria, Panax ginseng, Cordyceps militaris, Camellia sinensis, Cotinus coggygria, and Piper nigrum. | Dietary Supplement: LLP-01<br>* Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.<br>|
| Placebo Comparator: Placebo Group<br>Participants in this arm will receive Placebo capsules, which are visually identical to the capsules in the Experimental Group. These placebo capsules are filled with rice flour and a minor amount of Curcuma longa powder and should be taken in the same manner as the Experimental Group, with 2 capsules taken once daily without food for 60 days. | Other: Placebo<br>* Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Proteomic Changes | 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. | Change from baseline to 60 days and compared to placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic Age | Serum epigenetic aging test measuring changes in methylation patterns on DNA | Change from baseline to 60 days and compared to placebo | 
| Grip Strength | Digital grip strength device to measure absolute grip strength | Change from baseline to 60 days and compared to placebo | 
| Weight/BMI | Height and weight to measuring absolute weight and to calculate BMI | Change from baseline to 60 days and compared to placebo | 
| Well-being | Questionnaire covering different aspects of well-being | Change from baseline to 60 days and compared to placebo |