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

NCT ID: NCT06065241

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2024-03-28

Brief Summary

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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 and cardiovascular biomarkers .

Detailed Description

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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 and cardiovascular proteomic biomarkers. 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.

Conditions

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Aging Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 month, double blind placebo controlled study.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

LLP-01

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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LLP-01

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LL Prosper Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adi Ramon, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Chief Compliance Officer

Locations

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LL Prosper Inc.

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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SDLLP-01

Identifier Type: -

Identifier Source: org_study_id

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