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

Sponsor

LL Prosper Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06065241

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Inflammation	Dietary Supplement: LLP-01 Other: Placebo	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 month, double blind placebo controlled study.2 month, double blind placebo controlled study.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

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.

Anticipated Study Start Date :

Sep 27, 2023

Anticipated Primary Completion Date :

Nov 28, 2023

Anticipated Study Completion Date :

Nov 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group 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 Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.
Placebo Comparator: Placebo Group 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 Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.

Arm

Intervention/Treatment

Experimental: Experimental Group

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

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

Placebo Comparator: Placebo Group

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

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

Outcome Measures

Primary Outcome Measures

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

Epigenetic Age [Change from baseline to 60 days and compared to placebo]
Serum epigenetic aging test measuring changes in methylation patterns on DNA
Grip Strength [Change from baseline to 60 days and compared to placebo]
Digital grip strength device to measure absolute grip strength
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LL Prosper Inc.	San Diego	California	United States	92121

Sponsors and Collaborators

LL Prosper Inc.

Investigators

Principal Investigator: Adi Ramon, M.Sc, Chief Compliance Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LL Prosper Inc.

ClinicalTrials.gov Identifier:

NCT06065241

Other Study ID Numbers:

SDLLP-01

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Oct 3, 2023