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

Aging Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06065241
• Other study ID #: SDLLP-01
• Status: Completed
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: March 28, 2024

Study information

• Verified date: April 2024
• Source: LL Prosper Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Inflammation

Intervention

Dietary Supplement:
• LLP-01
Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.

Other:
• Placebo
Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.

Locations

Country	Name	City	State
United States	LL Prosper Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
LL Prosper Inc.

Country where clinical trial is conducted

United States, 

Outcome

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