search
Back to results

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

Primary Purpose

Aging, Inflammation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LLP-01
Placebo
Sponsored by
LL Prosper Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • LL Prosper Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Epigenetic Age
Serum epigenetic aging test measuring changes in methylation patterns on DNA
Grip Strength
Digital grip strength device to measure absolute grip strength
Weight/BMI
Height and weight to measuring absolute weight and to calculate BMI
Well-being
Questionnaire covering different aspects of well-being

Full Information

First Posted
September 26, 2023
Last Updated
October 16, 2023
Sponsor
LL Prosper Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06065241
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LL Prosper Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 month, double blind placebo controlled study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
LLP-01
Intervention Description
Participants in the experimental group will take 2 capsules daily containing 1,000mg of the formulation, LLP-01, for 60 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants in the placebo group will take 2 capsules daily containing rice flower and small amount of Curcuma Longa for 60 days.
Primary Outcome Measure Information:
Title
Plasma Proteomic Changes
Description
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.
Time Frame
Change from baseline to 60 days and compared to placebo
Secondary Outcome Measure Information:
Title
Epigenetic Age
Description
Serum epigenetic aging test measuring changes in methylation patterns on DNA
Time Frame
Change from baseline to 60 days and compared to placebo
Title
Grip Strength
Description
Digital grip strength device to measure absolute grip strength
Time Frame
Change from baseline to 60 days and compared to placebo
Title
Weight/BMI
Description
Height and weight to measuring absolute weight and to calculate BMI
Time Frame
Change from baseline to 60 days and compared to placebo
Title
Well-being
Description
Questionnaire covering different aspects of well-being
Time Frame
Change from baseline to 60 days and compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adi Ramon, M.Sc
Organizational Affiliation
Chief Compliance Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
LL Prosper Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs