Clinical trial NCT06065241: Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
Official title: Randomized Double Blind Placebo-controlled Trial to Investigate the Effect of a Botanical Formulation, LLP-01, on Proteomic Inflammatory Biomarkers and Epigenetic Changes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Inflammation
Lead sponsor: LL Prosper Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 month, double blind placebo controlled study.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Proteomic Changes
timeFrame: Change from baseline to 60 days and compared to placebo
Secondary outcomes:
measure: Epigenetic Age
timeFrame: Change from baseline to 60 days and compared to placebo
measure: Grip Strength
timeFrame: Change from baseline to 60 days and compared to placebo
measure: Weight/BMI
timeFrame: Change from baseline to 60 days and compared to placebo
measure: Well-being
timeFrame: Change from baseline to 60 days and compared to placebo
Other outcomes:
Locations:
city: San Diego
country: United States
facility: LL Prosper Inc.
state: California
Study officials:
affiliation: Chief Compliance Officer
name: Adi Ramon, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: