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

Not Applicable

Completed

• Conditions: Inflammation; Aging
• Interventions: Other: Placebo; Dietary Supplement: LLP-01

• Registration Number: NCT06065241
• Lead Sponsor: LL Prosper Inc.

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 Timeline

• Study Start: 2023-09-22
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-03
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	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.
Experimental Group	LLP-01	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.

Primary Outcome Measures

Name	Time	Method
Plasma Proteomic Changes	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 Outcome Measures

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

Trial Locations

Locations (1)

LL Prosper Inc.; 🇺🇸 San Diego, California, United States